🔍 RecallPedia

Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No. H7493919312200, EMERGE MR, OUS 2.00mm X 12mm; 4. REF/Catalog No. H7493918912250, EMERGE MR US 2.50MM X 12MM; 5. REF/Catalog No. H7493919312250, EMERGE MR, OUS 2.50mm X 12mm; 6. REF/Catalog No. H7493918912300, EMERGE MR US 3.00MM X 12MM; 7. REF/Catalog No. H7493919312300, EMERGE MR, OUS 3.00mm X 12mm; 8. REF/Catalog No. H7493918915150, EMERGE MR US 1.50MM X 15MM; 9. REF/Catalog No. H7493919315150, EMERGE MR, OUS 1.50mm X 15mm; 10. REF/Catalog No. H7493918915200, EMERGE MR US 2.00MM X 15MM, 11. REF/Catalog No. H7493919315200, EMERGE MR, OUS 2.00mm X 15mm; 12. REF/Catalog No. H7493919315250, EMERGE MR, OUS 2.50mm X 15mm; 13. REF/Catalog No. H7493918915300, EMERGE MR US 3.00MM X 15MM; 14. REF/Catalog No. H7493919315300, EMERGE MR, OUS 3.00mm X 15mm; 15. REF/Catalog No. H7493918915350, EMERGE MR US 3.50MM X 15MM; 16. REF/Catalog No. H7493919315350, EMERGE MR, OUS 3.50mm X 15mm; 17. REF/Catalog No. H7493919320200, EMERGE MR, OUS 2.00mm X 20mm; 18. REF/Catalog No. H7493919320250, EMERGE MR, OUS 2.50mm X 20mm; 19. REF/Catalog No. H7493919320300, EMERGE MR, OUS 3.00mm X 20mm; 20. REF/Catalog No. H7493919415120, EMERGE PUSH MR, OUS 1.20mm X 15mm.

Class I - Dangerous
🏥 Medical Devices Recalled: October 24, 2019 Boston Scientific Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot / GTIN Number / Use By: 1. 24112923 / 8714729799788 / 2022-03-12 2. Lot: 21362152 / 8714729806080 / 2020-07-06, 3. Lots: 21311605 / 8714729799894 / 2020-06-23, 23960557 / 8714729799894 / 2022-02-11, 23975925 / 8714729799894 / 2022-02-13, 24112926 / 8714729799894 / 2022-03-12. 4. Lots: 20524227 / 8714729806103 / 2019-12-31, 22402212 / 8714729806103 / 2021-03-15, 22909685 / 8714729806103 / 2020-12-06. 5. Lots: 23881230 / 8714729799917 / 2022-01-25, 23881291 / 8714729799917 / 2022-01-25, 24088571 / 8714729799917 / 2022-03-07, 24143068 / 8714729799917 / 2022-03-18. 6. Lots: 22374160 / 8714729806127 / 2021-03-09, 22532219 / 8714729806127 / 2021-04-16, 22760617 / 8714729806127 / 2021-02-05, 23021557 / 8714729806127 / 2021-01-11, 23181062 / 8714729806127 / 2021-09-10, 23578933 / 8714729806127 / 2021-04-16. 7. Lot: 22799195 / 8714729799931 / 2021-06-12. 8. Lots: 20361236 / 8714729806189 / 2019-10-31, 22619082 / 8714729806189 / 2021-05-03. 9. Lot: 24088574 / 8714729799993 / 2022-03-07. 10. Lots: 20985435 / 8714729806196 / 2020-04-04, 22416559 / 8714729806196 / 2021-03-19. 11. Lots: 21308852 / 8714729800002 / 2020-06-23, 21309387 / 8714729800002 / 2020-06-23, 21363021 / 8714729800002 / 2020-07-06, 23989173 / 8714729800002 / 2022-02-15. 12. Lots: 20909603 / 8714729800026 / 2020-03-15, 22734757 / 8714729800026 / 2021-05-29, 23047327 / 8714729800026 / 2021-08-03, 23946181 / 8714729800026 / 222-02-07, 24151134 / 8714729800026 / 2022-03-19. 13. Lot: 23924000 / 8714729806233 / 2022-02-04. 14. Lots: 23272475 /8714729800040 / 2021-09-27 , 23541254 / 8714729800040 / 2021-11-20. 15. Lot: 23901505 / 8714729806257 / 2022-01-30. 16. Lot: 24133473 / 8714729800064 / 2022-03-15. 17. Lots: 23272477 / 8714729800118 / 2021-09-21, 23324727 / 8714729800118 / 2021-10-08. 18. Lots: 20452512 / 8714729800132 / 2019-11-30, 20669615 / 8714729800132 / 2020-01-15, 23408005 / 8714729800132 / 2021-10-24. 19. Lots: 21500615 / 8714729800156 / 2020-08-08, 23518523 / 8714729800156 / 2021-11-15. 20. Lot: 23364688 / 8714729799702 / 2021-10-16.
  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:
Boston Scientific Corporation
Reason for Recall:
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No. H7493919312200, EMERGE MR, OUS 2.00mm X 12mm; 4. REF/Catalog No. H7493918912250, EMERGE MR US 2.50MM X 12MM; 5. REF/Catalog No. H7493919312250, EMERGE MR, OUS 2.50mm X 12mm; 6. REF/Catalog No. H7493918912300, EMERGE MR US 3.00MM X 12MM; 7. REF/Catalog No. H7493919312300, EMERGE MR, OUS 3.00mm X 12mm; 8. REF/Catalog No. H7493918915150, EMERGE MR US 1.50MM X 15MM; 9. REF/Catalog No. H7493919315150, EMERGE MR, OUS 1.50mm X 15mm; 10. REF/Catalog No. H7493918915200, EMERGE MR US 2.00MM X 15MM, 11. REF/Catalog No. H7493919315200, EMERGE MR, OUS 2.00mm X 15mm; 12. REF/Catalog No. H7493919315250, EMERGE MR, OUS 2.50mm X 15mm; 13. REF/Catalog No. H7493918915300, EMERGE MR US 3.00MM X 15MM; 14. REF/Catalog No. H7493919315300, EMERGE MR, OUS 3.00mm X 15mm; 15. REF/Catalog No. H7493918915350, EMERGE MR US 3.50MM X 15MM; 16. REF/Catalog No. H7493919315350, EMERGE MR, OUS 3.50mm X 15mm; 17. REF/Catalog No. H7493919320200, EMERGE MR, OUS 2.00mm X 20mm; 18. REF/Catalog No. H7493919320250, EMERGE MR, OUS 2.50mm X 20mm; 19. REF/Catalog No. H7493919320300, EMERGE MR, OUS 3.00mm X 20mm; 20. REF/Catalog No. H7493919415120, EMERGE PUSH MR, OUS 1.20mm X 15mm.

Product Codes/Lot Numbers:

Lot / GTIN Number / Use By: 1. 24112923 / 8714729799788 / 2022-03-12 2. Lot: 21362152 / 8714729806080 / 2020-07-06, 3. Lots: 21311605 / 8714729799894 / 2020-06-23, 23960557 / 8714729799894 / 2022-02-11, 23975925 / 8714729799894 / 2022-02-13, 24112926 / 8714729799894 / 2022-03-12. 4. Lots: 20524227 / 8714729806103 / 2019-12-31, 22402212 / 8714729806103 / 2021-03-15, 22909685 / 8714729806103 / 2020-12-06. 5. Lots: 23881230 / 8714729799917 / 2022-01-25, 23881291 / 8714729799917 / 2022-01-25, 24088571 / 8714729799917 / 2022-03-07, 24143068 / 8714729799917 / 2022-03-18. 6. Lots: 22374160 / 8714729806127 / 2021-03-09, 22532219 / 8714729806127 / 2021-04-16, 22760617 / 8714729806127 / 2021-02-05, 23021557 / 8714729806127 / 2021-01-11, 23181062 / 8714729806127 / 2021-09-10, 23578933 / 8714729806127 / 2021-04-16. 7. Lot: 22799195 / 8714729799931 / 2021-06-12. 8. Lots: 20361236 / 8714729806189 / 2019-10-31, 22619082 / 8714729806189 / 2021-05-03. 9. Lot: 24088574 / 8714729799993 / 2022-03-07. 10. Lots: 20985435 / 8714729806196 / 2020-04-04, 22416559 / 8714729806196 / 2021-03-19. 11. Lots: 21308852 / 8714729800002 / 2020-06-23, 21309387 / 8714729800002 / 2020-06-23, 21363021 / 8714729800002 / 2020-07-06, 23989173 / 8714729800002 / 2022-02-15. 12. Lots: 20909603 / 8714729800026 / 2020-03-15, 22734757 / 8714729800026 / 2021-05-29, 23047327 / 8714729800026 / 2021-08-03, 23946181 / 8714729800026 / 222-02-07, 24151134 / 8714729800026 / 2022-03-19. 13. Lot: 23924000 / 8714729806233 / 2022-02-04. 14. Lots: 23272475 /8714729800040 / 2021-09-27 , 23541254 / 8714729800040 / 2021-11-20. 15. Lot: 23901505 / 8714729806257 / 2022-01-30. 16. Lot: 24133473 / 8714729800064 / 2022-03-15. 17. Lots: 23272477 / 8714729800118 / 2021-09-21, 23324727 / 8714729800118 / 2021-10-08. 18. Lots: 20452512 / 8714729800132 / 2019-11-30, 20669615 / 8714729800132 / 2020-01-15, 23408005 / 8714729800132 / 2021-10-24. 19. Lots: 21500615 / 8714729800156 / 2020-08-08, 23518523 / 8714729800156 / 2021-11-15. 20. Lot: 23364688 / 8714729799702 / 2021-10-16.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0577-2020

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