BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Device Listing: D222541 Product Code/Lot Number/UDI MC1410 - 114g x10cm RECN0753/(01)00801741084423(17)201231(10)RECN0753 REDR1996/(01)00801741084423(17)220331(10)REDR1996 REDS0461/(01)00801741084423(17)220331(10)REDS0461 MC1416 - 14 g x 16 cm RECP1763/(01)00801741084430(17)210228(10)RECP1763 MC1610 - 16 g x 10 cm RECN0756/(01)00801741084447(17)201231(10)RECN0756 RECN1632/(01)00801741084447(17)201231(10)RECN1632 REDN2403/(01)00801741084447(17)211231(10)REDN2403 REDN2448/(01)00801741084447(17)211231(10)REDN2448 REDN3426/(01)00801741084447(17)211231(10)REDN3426 REDP0046/(01)00801741084447(17)211231(10)REDP0046 REDQ2463/(01)00801741084447(17)220228(10)REDQ2463 REDR1997/(01)00801741084447(17)220331(10)REDR1997 REDS1470/(01)00801741084447(17)220430(10)REDS1470 REDS2663/(01)00801741084447(17)220430(10)REDS2663 REDS3864/(01)00801741084447(17)220430(10)REDS3864 REDS4214/(01)00801741084447(17)220430(10)REDS4214 REDT1884/(01)00801741084447(17)220531(10)REDT1884 REDT4419/(01)00801741084447(17)220531(10)REDT4419 REDU1687/(01)00801741084447(17)220630(10)REDU1687 REDU2579/(01)00801741084447(17)220630(10)REDU2579 MC1616 - 16 g x 16 cm RECN2119/(01)00801741084454(17)210131(10)RECN2119 RECP2400/(01)00801741084454(17)210228(10)RECP2400 REDN2402/(01)00801741084454(17)211231(10)REDN2402 REDN2447/(01)00801741084454(17)211231(10)REDN2447 REDN3457/(01)00801741084454(17)211231(10)REDN3457 REDP0085/(01)00801741084454(17)211231(10)REDP0085 REDQ2460/(01)00801741084454(17)220228(10)REDQ2460 REDQ4100/(01)00801741084454(17)220228(10)REDQ4100 REDR0746/(01)00801741084454(17)220331(10)REDR0746 REDR2055/(01)00801741084454(17)220331(10)REDR2055 REDS0420/(01)00801741084454(17)220331(10)REDS0420 REDS1471/(01)00801741084454(17)220430(10)REDS1471 REDS2594/(01)00801741084454(17)220430(10)REDS2594 REDS2595/(01)00801741084454(17)220430(10)REDS2595 REDS2664/(01)00801741084454(17)220430(10)REDS2664 REDS3750/(01)00801741084454(17)220430(10)REDS3750 REDT0879/(01)00801741084454(17)220531(10)REDT0879 REDT2007/(01)00801741084454(17)220531(10)REDT2007 REDT3043/(01)00801741084454(17)220531(10)REDT3043 REDU0929/(01)00801741084454(17)220630(10)REDU0929 REDU3571/(01)00801741084454(17)220630(10)REDU3571 REDU4536/(01)00801741084454(17)220630(10)REDU4536 REDV1435/(01)00801741084454(17)220731(10)REDV1435 REDV2354/(01)00801741084454(17)220731(10)REDV2354 MC1810 - 18 g x 10 cm RECN2069/(01)00801741084461(17)210131(10)RECN2069 REDN0266/(01)00801741084461(17)211231(10)REDN0266 REDN1612/(01)00801741084461(17)211231(10)REDN1612 REDN3443/(01)00801741084461(17)211231(10)REDN3443 REDP0047/(01)00801741084461(17)211231(10)REDP0047 REDP2162/(01)00801741084461(17)220131(10)REDP2162 REDP3393/(01)00801741084461(17)220131(10)REDP3393 REDP4637/(01)00801741084461(17)220131(10)REDP4637 REDQ0871/(01)00801741084461(17)220228(10)REDQ0871 REDQ2499/(01)00801741084461(17)220228(10)REDQ2499 REDQ2502/(01)00801741084461(17)220228(10)REDQ2502 REDR0676/(01)00801741084461(17)220331(10)REDR0676 REDR1998/(01)00801741084461(17)220331(10)REDR1998 REDS0469/(01)00801741084461(17)220331(10)REDS0469 REDS1610/(01)00801741084461(17)220430(10)REDS1610 REDS2665/(01)00801741084461(17)220430(10)REDS2665 REDS3865/(01)00801741084461(17)220430(10)REDS3865 REDS4215/(01)00801741084461(17)220430(10)REDS4215 REDT0926/(01)00801741084461(17)220531(10)REDT0926 REDT1885/(01)00801741084461(17)220531(10)REDT1885 REDT4420/(01)00801741084461(17)220531(10)REDT4420 REDU0922/(01)00801741084461(17)220630(10)REDU0922 REDU2476/(01)00801741084461(17)220630(10)REDU2476 REDU3498/(01)00801741084461(17)220630(10)REDU3498 REDU4566/(01)00801741084461(17)220630(10)REDU4566 REDV1369/(01)00801741084461(17)220731(10)REDV1369 REDV3016/(01)00801741084461(17)220731(10)REDV3016 MC1816 - 18 g x 16 cm RECZ2179/(01)00801741084478(17)211130(10)RECZ2179 RECZ3084/(01)00801741084478(17)211130(10)RECZ3084 RECZ3178/(01)00801741084478(17)211130(10)RECZ3178 REDN2401/(01)00801741084478(17)211231(10)REDN2401 REDQ0848/(01)00801741084478(17)220228(10)REDQ0848 REDR0747/(01)00801741084478(17)220331(10)REDR0747 REDR1989/(01)00801741084478(17)220331(10)REDR1989 REDR3627/(01)00801741084478(17)220331(10)REDR3627 REDS0421/(01)00801741084478(17)220331(10)REDS0421 REDS1484/(01)00801741084478(17)220430(10)REDS1484 MC1820 - 18 g x 20 cm REBZ0283/(01)00801741084485(17)201130(10)REBZ0283 RECN0654/(01)00801741084485(17)201231(10)RECN0654 RECN0760/(01)00801741084485(17)201231(10)RECN0760 RECN1633/(01)00801741084485(17)210131(10)RECN1633 RECN1634/(01)00801741084485(17)210131(10)RECN1634 RECN2091/(01)00801741084485(17)210131(10)RECN2091 RECN2120/(01)00801741084485(17)210131(10)RECN2120 RECP0263/(01)00801741084485(17)210131(10)RECP0263 RECP1251/(01)00801741084485(17)210228(10)RECP1251 RECP1252/(01)00801741084485(17)210131(10)RECP1252 RECP1765/(01)00801741084485(17)210228(10)RECP1765 RECP1988/(01)00801741084485(17)210228(10)RECP1988 RECQ0331/(01)00801741084485(17)210228(10)RECQ0331 RECQ0592/(01)00801741084485(17)210228(10)RECQ0592 RECQ1208/(01)00801741084485(17)210228(10)RECQ1208 RECQ1651/(01)00801741084485(17)210228(10)RECQ1651 RECQ1997/(01)00801741084485(17)210331(10)RECQ1997 RECZ3012/(01)00801741084485(17)211130(10)RECZ3012 RECZ3015/(01)00801741084485(17)211130(10)RECZ3015 RECZ3114/(01)00801741084485(17)211130(10)RECZ3114 RECZ3132/(01)00801741084485(17)211130(10)RECZ3132 RECZ3167/(01)00801741084485(17)211130(10)RECZ3167 RECZ3176/(01)00801741084485(17)211130(10)RECZ3176 REDN0295/(01)00801741084485(17)211231(10)REDN0295 REDN1613/(01)00801741084485(17)211231(10)REDN1613 REDN2400/(01)00801741084485(17)211231(10)REDN2400 REDN2445/(01)00801741084485(17)211231(10)REDN2445 REDN3423/(01)00801741084485(17)211231(10)REDN3423 REDN3424/(01)00801741084485(17)211231(10)REDN3424 REDP0048/(01)00801741084485(17)211231(10)REDP0048 REDP1474/(01)00801741084485(17)220131(10)REDP1474 REDP1482/(01)00801741084485(17)220131(10)REDP1482 REDP2160/(01)00801741084485(17)220131(10)REDP2160 REDP3392/(01)00801741084485(17)220131(10)REDP3392 REDP4638/(01)00801741084485(17)220131(10)REDP4638 REDP5040/(01)00801741084485(17)220131(10)REDP5040 REDP5041/(01)00801741084485(17)220131(10)REDP5041 REDQ0849/(01)00801741084485(17)220228(10)REDQ0849 REDQ2461/(01)00801741084485(17)220228(10)REDQ2461 REDQ2503/(01)00801741084485(17)220228(10)REDQ2503 REDQ4101/(01)00801741084485(17)220228(10)REDQ4101 REDR0677/(01)00801741084485(17)220331(10)REDR0677 REDR2041/(01)00801741084485(17)220331(10)REDR2041 REDR2969/(01)00801741084485(17)220331(10)REDR2969 REDR3028/(01)00801741084485(17)220331(10)REDR3028 REDR3628/(01)00801741084485(17)220331(10)REDR3628 REDR3629/(01)00801741084485(17)220331(10)REDR3629 REDR3690/(01)00801741084485(17)220331(10)REDR3690 REDS0470/(01)00801741084485(17)220331(10)REDS0470 REDS1485/(01)00801741084485(17)220430(10)REDS1485 REDS1612/(01)00801741084485(17)220430(10)REDS1612 REDS2666/(01)00801741084485(17)220430(10)REDS2666 REDS3752/(01)00801741084485(17)220430(10)REDS3752 REDS3866/(01)00801741084485(17)220430(10)REDS3866 REDS4216/(01)00801741084485(17)220430(10)REDS4216 REDT0927/(01)00801741084485(17)220531(10)REDT0927 REDT1881/(01)00801741084485(17)220531(10)REDT1881 REDT3045/(01)00801741084485(17)220531(10)REDT3045 REDT3146/(01)00801741084485(17)220531(10)REDT3146 REDT4421/(01)00801741084485(17)220531(10)REDT4421 REDT4432/(01)00801741084485(17)220531(10)REDT4432 REDU0923/(01)00801741084485(17)220630(10)REDU0923 REDU0931/(01)00801741084485(17)220630(10)REDU0931 REDU1688/(01)00801741084485(17)220630(10)REDU1688 REDU1693/(01)00801741084485(17)220630(10)REDU1693 REDU2477/(01)00801741084485(17)220630(10)REDU2477 REDU2583/(01)00801741084485(17)220630(10)REDU2583 REDU3499/(01)00801741084485(17)220630(10)REDU3499 REDU4538/(01)00801741084485(17)220630(10)REDU4538 REDU4568/(01)00801741084485(17)220630(10)REDU4568 REDV1370/(01)00801741084485(17)220731(10)REDV1370 REDV1437/(01)00801741084485(17)220731(10)REDV1437 REDV2355/(01)00801741084485(17)220731(10)REDV2355 REDV3017/(01)00801741084485(17)220731(10)REDV3017 REDV3018/(01)00801741084485(17)220731(10)REDV3018 REDV3100/(01)00801741084485(17)220731(10)REDV3100 REDV3791/(01)00801741084485(17)220731(10)REDV3791 MC1825 - 18 g x 25 cm RECN1140/(01)00801741084492(17)201231(10)RECN1140 RECN1804/(01)00801741084492(17)210131(10)RECN1804 RECP0227/(01)00801741084492(17)210131(10)RECP0227 REDN1614/(01)00801741084492(17)211231(10)REDN1614 REDN2444/(01)00801741084492(17)211231(10)REDN2444 REDN3461/(01)00801741084492(17)211231(10)REDN3461 REDQ2498/(01)00801741084492(17)220228(10)REDQ2498 REDQ2976/(01)00801741084492(17)220228(10)REDQ2976 MC2016 - 20 g x 16 cm REDT0928/(01)00801741084515(17)220531(10)REDT0928 REDT1882/(01)00801741084515(17)220531(10)REDT1882 REDT3150/(01)00801741084515(17)220531(10)REDT3150 REDT4423/(01)00801741084515(17)220531(10)REDT4423 REDV1438/(01)00801741084515(17)220731(10)REDV1438 REDV2329/(01)00801741084515(17)220731(10)REDV2329 MC2020 - 20 g x 20 cm REDV1372/(01)00801741084522(17)220731(10)REDV1372 REDV2357/(01)00801741084522(17)220731(10)REDV2357
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Bard Peripheral Vascular Inc
Reason for Recall:
During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Product Codes/Lot Numbers:

Device Listing: D222541 Product Code/Lot Number/UDI MC1410 - 114g x10cm RECN0753/(01)00801741084423(17)201231(10)RECN0753 REDR1996/(01)00801741084423(17)220331(10)REDR1996 REDS0461/(01)00801741084423(17)220331(10)REDS0461 MC1416 - 14 g x 16 cm RECP1763/(01)00801741084430(17)210228(10)RECP1763 MC1610 - 16 g x 10 cm RECN0756/(01)00801741084447(17)201231(10)RECN0756 RECN1632/(01)00801741084447(17)201231(10)RECN1632 REDN2403/(01)00801741084447(17)211231(10)REDN2403 REDN2448/(01)00801741084447(17)211231(10)REDN2448 REDN3426/(01)00801741084447(17)211231(10)REDN3426 REDP0046/(01)00801741084447(17)211231(10)REDP0046 REDQ2463/(01)00801741084447(17)220228(10)REDQ2463 REDR1997/(01)00801741084447(17)220331(10)REDR1997 REDS1470/(01)00801741084447(17)220430(10)REDS1470 REDS2663/(01)00801741084447(17)220430(10)REDS2663 REDS3864/(01)00801741084447(17)220430(10)REDS3864 REDS4214/(01)00801741084447(17)220430(10)REDS4214 REDT1884/(01)00801741084447(17)220531(10)REDT1884 REDT4419/(01)00801741084447(17)220531(10)REDT4419 REDU1687/(01)00801741084447(17)220630(10)REDU1687 REDU2579/(01)00801741084447(17)220630(10)REDU2579 MC1616 - 16 g x 16 cm RECN2119/(01)00801741084454(17)210131(10)RECN2119 RECP2400/(01)00801741084454(17)210228(10)RECP2400 REDN2402/(01)00801741084454(17)211231(10)REDN2402 REDN2447/(01)00801741084454(17)211231(10)REDN2447 REDN3457/(01)00801741084454(17)211231(10)REDN3457 REDP0085/(01)00801741084454(17)211231(10)REDP0085 REDQ2460/(01)00801741084454(17)220228(10)REDQ2460 REDQ4100/(01)00801741084454(17)220228(10)REDQ4100 REDR0746/(01)00801741084454(17)220331(10)REDR0746 REDR2055/(01)00801741084454(17)220331(10)REDR2055 REDS0420/(01)00801741084454(17)220331(10)REDS0420 REDS1471/(01)00801741084454(17)220430(10)REDS1471 REDS2594/(01)00801741084454(17)220430(10)REDS2594 REDS2595/(01)00801741084454(17)220430(10)REDS2595 REDS2664/(01)00801741084454(17)220430(10)REDS2664 REDS3750/(01)00801741084454(17)220430(10)REDS3750 REDT0879/(01)00801741084454(17)220531(10)REDT0879 REDT2007/(01)00801741084454(17)220531(10)REDT2007 REDT3043/(01)00801741084454(17)220531(10)REDT3043 REDU0929/(01)00801741084454(17)220630(10)REDU0929 REDU3571/(01)00801741084454(17)220630(10)REDU3571 REDU4536/(01)00801741084454(17)220630(10)REDU4536 REDV1435/(01)00801741084454(17)220731(10)REDV1435 REDV2354/(01)00801741084454(17)220731(10)REDV2354 MC1810 - 18 g x 10 cm RECN2069/(01)00801741084461(17)210131(10)RECN2069 REDN0266/(01)00801741084461(17)211231(10)REDN0266 REDN1612/(01)00801741084461(17)211231(10)REDN1612 REDN3443/(01)00801741084461(17)211231(10)REDN3443 REDP0047/(01)00801741084461(17)211231(10)REDP0047 REDP2162/(01)00801741084461(17)220131(10)REDP2162 REDP3393/(01)00801741084461(17)220131(10)REDP3393 REDP4637/(01)00801741084461(17)220131(10)REDP4637 REDQ0871/(01)00801741084461(17)220228(10)REDQ0871 REDQ2499/(01)00801741084461(17)220228(10)REDQ2499 REDQ2502/(01)00801741084461(17)220228(10)REDQ2502 REDR0676/(01)00801741084461(17)220331(10)REDR0676 REDR1998/(01)00801741084461(17)220331(10)REDR1998 REDS0469/(01)00801741084461(17)220331(10)REDS0469 REDS1610/(01)00801741084461(17)220430(10)REDS1610 REDS2665/(01)00801741084461(17)220430(10)REDS2665 REDS3865/(01)00801741084461(17)220430(10)REDS3865 REDS4215/(01)00801741084461(17)220430(10)REDS4215 REDT0926/(01)00801741084461(17)220531(10)REDT0926 REDT1885/(01)00801741084461(17)220531(10)REDT1885 REDT4420/(01)00801741084461(17)220531(10)REDT4420 REDU0922/(01)00801741084461(17)220630(10)REDU0922 REDU2476/(01)00801741084461(17)220630(10)REDU2476 REDU3498/(01)00801741084461(17)220630(10)REDU3498 REDU4566/(01)00801741084461(17)220630(10)REDU4566 REDV1369/(01)00801741084461(17)220731(10)REDV1369 REDV3016/(01)00801741084461(17)220731(10)REDV3016 MC1816 - 18 g x 16 cm RECZ2179/(01)00801741084478(17)211130(10)RECZ2179 RECZ3084/(01)00801741084478(17)211130(10)RECZ3084 RECZ3178/(01)00801741084478(17)211130(10)RECZ3178 REDN2401/(01)00801741084478(17)211231(10)REDN2401 REDQ0848/(01)00801741084478(17)220228(10)REDQ0848 REDR0747/(01)00801741084478(17)220331(10)REDR0747 REDR1989/(01)00801741084478(17)220331(10)REDR1989 REDR3627/(01)00801741084478(17)220331(10)REDR3627 REDS0421/(01)00801741084478(17)220331(10)REDS0421 REDS1484/(01)00801741084478(17)220430(10)REDS1484 MC1820 - 18 g x 20 cm REBZ0283/(01)00801741084485(17)201130(10)REBZ0283 RECN0654/(01)00801741084485(17)201231(10)RECN0654 RECN0760/(01)00801741084485(17)201231(10)RECN0760 RECN1633/(01)00801741084485(17)210131(10)RECN1633 RECN1634/(01)00801741084485(17)210131(10)RECN1634 RECN2091/(01)00801741084485(17)210131(10)RECN2091 RECN2120/(01)00801741084485(17)210131(10)RECN2120 RECP0263/(01)00801741084485(17)210131(10)RECP0263 RECP1251/(01)00801741084485(17)210228(10)RECP1251 RECP1252/(01)00801741084485(17)210131(10)RECP1252 RECP1765/(01)00801741084485(17)210228(10)RECP1765 RECP1988/(01)00801741084485(17)210228(10)RECP1988 RECQ0331/(01)00801741084485(17)210228(10)RECQ0331 RECQ0592/(01)00801741084485(17)210228(10)RECQ0592 RECQ1208/(01)00801741084485(17)210228(10)RECQ1208 RECQ1651/(01)00801741084485(17)210228(10)RECQ1651 RECQ1997/(01)00801741084485(17)210331(10)RECQ1997 RECZ3012/(01)00801741084485(17)211130(10)RECZ3012 RECZ3015/(01)00801741084485(17)211130(10)RECZ3015 RECZ3114/(01)00801741084485(17)211130(10)RECZ3114 RECZ3132/(01)00801741084485(17)211130(10)RECZ3132 RECZ3167/(01)00801741084485(17)211130(10)RECZ3167 RECZ3176/(01)00801741084485(17)211130(10)RECZ3176 REDN0295/(01)00801741084485(17)211231(10)REDN0295 REDN1613/(01)00801741084485(17)211231(10)REDN1613 REDN2400/(01)00801741084485(17)211231(10)REDN2400 REDN2445/(01)00801741084485(17)211231(10)REDN2445 REDN3423/(01)00801741084485(17)211231(10)REDN3423 REDN3424/(01)00801741084485(17)211231(10)REDN3424 REDP0048/(01)00801741084485(17)211231(10)REDP0048 REDP1474/(01)00801741084485(17)220131(10)REDP1474 REDP1482/(01)00801741084485(17)220131(10)REDP1482 REDP2160/(01)00801741084485(17)220131(10)REDP2160 REDP3392/(01)00801741084485(17)220131(10)REDP3392 REDP4638/(01)00801741084485(17)220131(10)REDP4638 REDP5040/(01)00801741084485(17)220131(10)REDP5040 REDP5041/(01)00801741084485(17)220131(10)REDP5041 REDQ0849/(01)00801741084485(17)220228(10)REDQ0849 REDQ2461/(01)00801741084485(17)220228(10)REDQ2461 REDQ2503/(01)00801741084485(17)220228(10)REDQ2503 REDQ4101/(01)00801741084485(17)220228(10)REDQ4101 REDR0677/(01)00801741084485(17)220331(10)REDR0677 REDR2041/(01)00801741084485(17)220331(10)REDR2041 REDR2969/(01)00801741084485(17)220331(10)REDR2969 REDR3028/(01)00801741084485(17)220331(10)REDR3028 REDR3628/(01)00801741084485(17)220331(10)REDR3628 REDR3629/(01)00801741084485(17)220331(10)REDR3629 REDR3690/(01)00801741084485(17)220331(10)REDR3690 REDS0470/(01)00801741084485(17)220331(10)REDS0470 REDS1485/(01)00801741084485(17)220430(10)REDS1485 REDS1612/(01)00801741084485(17)220430(10)REDS1612 REDS2666/(01)00801741084485(17)220430(10)REDS2666 REDS3752/(01)00801741084485(17)220430(10)REDS3752 REDS3866/(01)00801741084485(17)220430(10)REDS3866 REDS4216/(01)00801741084485(17)220430(10)REDS4216 REDT0927/(01)00801741084485(17)220531(10)REDT0927 REDT1881/(01)00801741084485(17)220531(10)REDT1881 REDT3045/(01)00801741084485(17)220531(10)REDT3045 REDT3146/(01)00801741084485(17)220531(10)REDT3146 REDT4421/(01)00801741084485(17)220531(10)REDT4421 REDT4432/(01)00801741084485(17)220531(10)REDT4432 REDU0923/(01)00801741084485(17)220630(10)REDU0923 REDU0931/(01)00801741084485(17)220630(10)REDU0931 REDU1688/(01)00801741084485(17)220630(10)REDU1688 REDU1693/(01)00801741084485(17)220630(10)REDU1693 REDU2477/(01)00801741084485(17)220630(10)REDU2477 REDU2583/(01)00801741084485(17)220630(10)REDU2583 REDU3499/(01)00801741084485(17)220630(10)REDU3499 REDU4538/(01)00801741084485(17)220630(10)REDU4538 REDU4568/(01)00801741084485(17)220630(10)REDU4568 REDV1370/(01)00801741084485(17)220731(10)REDV1370 REDV1437/(01)00801741084485(17)220731(10)REDV1437 REDV2355/(01)00801741084485(17)220731(10)REDV2355 REDV3017/(01)00801741084485(17)220731(10)REDV3017 REDV3018/(01)00801741084485(17)220731(10)REDV3018 REDV3100/(01)00801741084485(17)220731(10)REDV3100 REDV3791/(01)00801741084485(17)220731(10)REDV3791 MC1825 - 18 g x 25 cm RECN1140/(01)00801741084492(17)201231(10)RECN1140 RECN1804/(01)00801741084492(17)210131(10)RECN1804 RECP0227/(01)00801741084492(17)210131(10)RECP0227 REDN1614/(01)00801741084492(17)211231(10)REDN1614 REDN2444/(01)00801741084492(17)211231(10)REDN2444 REDN3461/(01)00801741084492(17)211231(10)REDN3461 REDQ2498/(01)00801741084492(17)220228(10)REDQ2498 REDQ2976/(01)00801741084492(17)220228(10)REDQ2976 MC2016 - 20 g x 16 cm REDT0928/(01)00801741084515(17)220531(10)REDT0928 REDT1882/(01)00801741084515(17)220531(10)REDT1882 REDT3150/(01)00801741084515(17)220531(10)REDT3150 REDT4423/(01)00801741084515(17)220531(10)REDT4423 REDV1438/(01)00801741084515(17)220731(10)REDV1438 REDV2329/(01)00801741084515(17)220731(10)REDV2329 MC2020 - 20 g x 20 cm REDV1372/(01)00801741084522(17)220731(10)REDV1372 REDV2357/(01)00801741084522(17)220731(10)REDV2357

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0724-2020

Related Recalls

Class I - Dangerous

Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.

Nov 6, 2025 Surgical Instruments Nationwide View Details →

Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation.

Aug 21, 2025 Diagnostic Equipment Nationwide View Details →

Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.

Feb 5, 2025 Other Medical Devices Nationwide View Details →