🔍 RecallPedia

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

Class I - Dangerous
🏥 Medical Devices Recalled: April 29, 2024 ARROW INTERNATIONAL Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    a) REF IAB-05830-LWS, UDI: (01)10801902161892(17)241231(10)18F23A0038, (01)10801902161892(17)250131(10)18F23B0023, (01)10801902161892(17)250430(10)18F23D0024, (01)10801902161892(17)250731(10)18F23H0060, (01)10801902161892(17)250930(10)18F23J0075, (01)10801902161892(17)250930(10)18F23K0013, (01)10801902161892(17)251031(10)18F23L0019, (01)10801902161892(17)251031(10)18F23L0041, (01)10801902161892(17)260131(10)18F24B0008, (01)10801902161892(17)260228(10)18F24C0058, (01)10801902161892(17)260228(10)18F24C0101, (01)10801902161892(17)260331(10)18F24D0002, (01)10801902172843(17)250228(10)18F23C0026, (01)10801902172843(17)250531(10)18F23F0049, (01)10801902172843(17)250831(10)18F23J0001, (01)10801902172843(17)251031(10)18F23L0054, (01)10801902172843(17)251130(10)18F23M0056, (01)10801902172843(17)251231(10)18F24A0015, (01)10801902172843(17)260131(10)18F24A0040, (01)10801902172843(17)260131(10)18F24B0013, (01)10801902172843(17)260228(10)18F24C0061, (01)10801902172843(17)260228(10)18F24C0109, (01)10801902172843(17)260228(10)18F24C0110, (01)10801902172843(17)260331(10)18F24C0172, (01)10801902172843(17)260331(10)18F24C0173, (01)10801902172843(17)46112(10)18F24C0088, (01)10801902172843(17)46112(10)18F24C0089, (01)10801902172843(17)46112(10)18F24C0174, (01)10801902172843(17)46112(10)18F24C0175, (01)10801902172843(17)46112(10)18F24C0176, (01)10801902172843(17)46112(10)18F24C0185; b) REF IAB-05840-LWS, UDI: (01)10801902167733(17)240531(10)18F22F0072, (01)10801902167733(17)240630(10)18F22G0021, (01)10801902167733(17)240630(10)18F22G0031, (01)10801902167733(17)240630(10)18F22G0046, (01)10801902167733(17)240731(10)18F22H0009, (01)10801902167733(17)240731(10)18F22H0023, (01)10801902167733(17)240731(10)18F22H0058, (01)10801902167733(17)240930(10)18F22K0015, (01)10801902167733(17)241130(10)18F22M0017, (01)10801902167733(17)241130(10)18F22M0018, (01)10801902167733(17)241231(10)18F23A0004, (01)10801902167733(17)241231(10)18F23A0005, (01)10801902167733(17)241231(10)18F23A0018, (01)10801902167733(17)241231(10)18F23A0026, (01)10801902167733(17)250131(10)18F23B0008, (01)10801902167733(17)250131(10)18F23B0016, (01)10801902167733(17)250531(10)18F23E0054, (01)10801902167733(17)250630(10)18F23G0017, (01)10801902167733(17)250731(10)18F23H0029, (01)10801902167733(17)250731(10)18F23H0064, (01)10801902167733(17)251031(10)18F23L0009, (01)10801902167733(17)251031(10)18F23L0028, (01)10801902167733(17)251231(10)18F23M0068, (01)10801902167733(17)251231(10)18F24A0030, (01)10801902167733(17)251231(10)18F24A0039, (01)10801902167733(17)260131(10)18F24B0015, (01)10801902167733(17)260131(10)18F24B0031, (01)10801902167733(17)260228(10)18F24C0008, (01)10801902167733(17)260228(10)18F24C0069, (01)10801902167733(17)260228(10)18F24C0071, (01)10801902167733(17)260228(10)18F24C0072, (01)10801902167733(17)260228(10)18F24C0075, (01)10801902167733(17)260228(10)18F24C0076, (01)10801902167733(17)260228(10)18F24C0077, (01)10801902167733(17)260228(10)18F24C0078, (01)10801902167733(17)260228(10)18F24C0079, (01)10801902167733(17)260228(10)18F24C0080, (01)10801902167733(17)260228(10)18F24C0081, (01)10801902167733(17)260331(10)18F24C0083, (01)10801902167733(17)260331(10)18F24C0186, (01)10801902167733(17)260331(10)18F24C0187, (01)10801902167733(17)260331(10)18F24C0188, (01)10801902167733(17)260331(10)18F24C0193, (01)10801902167733(17)260331(10)18F24D0020, (01)10801902167733(17)260331(10)18F24D0021, (01)10801902167733(17)260331(10)18F24D0022, (01)10801902167733(17)260331(10)18F24D0031, (01)10801902167733(17)260331(10)18F24D0032, (01)10801902167733(17)260331(10)18F24D0037, (01)10801902167733(17)260331(10)18F24D0038, (01)10801902167733(17)260331(10)18F24D0039, (01)10801902167733(17)260331(10)18F24D0042, (01)10801902167733(17)260331(10)18F24D0044, (01)10801902167733(17)260331(10)18F24D0045, (01)10801902167733(17)260331(10)18F24D0049, (01)10801902167733(17)260331(10)18F24D0050, (01)10801902167733(17)260331(10)18F24D0051, (01)10801902167733(17)260331(10)18F24D0054, (01)10801902167733(17)260331(10)18F24D0055, (01)10801902167733(17)260331(10)18F24D0072, (01)10801902167733(17)260331(10)18F24D0087, (01)10801902167733(17)260331(10)18F24D0088, (01)10801902167733(17)260331(10)18F24D0089, (01)10801902167733(17)260331(10)18F24D0090, (01)10801902167733(17)260331(10)18F24D0091, (01)10801902167733(17)260331(10)18F24D0092, (01)10801902172867(17)240430(10)18F22E0008, (01)10801902172867(17)240430(10)18F22E0029, (01)10801902172867(17)240531(10)18F22F0006, (01)10801902172867(17)240531(10)18F22F0018, (01)10801902172867(17)240531(10)18F22F0039, (01)10801902172867(17)240630(10)18F22G0002, (01)10801902172867(17)240630(10)18F22G0003, (01)10801902172867(17)240630(10)18F22G0019, (01)10801902172867(17)240630(10)18F22G0059, (01)10801902172867(17)240731(10)18F22H0035, (01)10801902172867(17)240831(10)18F22J0025, (01)10801902172867(17)240930(10)18F22K0016, (01)10801902172867(17)250430(10)18F23E0020, (01)10801902172867(17)250531(10)18F23F0002, (01)10801902172867(17)250531(10)18F23F0026, (01)10801902172867(17)250630(10)18F23G0008, (01)10801902172867(17)250731(10)18F23G0057, (01)10801902172867(17)250731(10)18F23H0013, (01)10801902172867(17)250731(10)18F23H0055, (01)10801902172867(17)250831(10)18F23J0003, (01)10801902172867(17)250831(10)18F23J0037, (01)10801902172867(17)250831(10)18F23J0072, (01)10801902172867(17)250930(10)18F23J0073, (01)10801902172867(17)251031(10)18F23K0054, (01)10801902172867(17)251130(10)18F23L0055, (01)10801902172867(17)251130(10)18F23M0043, (01)10801902172867(17)251231(10)18F24A0025, (01)10801902172867(17)251231(10)18F24A0031, (01)10801902172867(17)260131(10)18F24B0005, (01)10801902172867(17)260131(10)18F24B0048, (01)10801902172867(17)260131(10)18F24B0052, (01)10801902172867(17)260228(10)18F24B0078, (01)10801902172867(17)260228(10)18F24C0036, (01)10801902172867(17)260228(10)18F24C0064, (01)10801902172867(17)260228(10)18F24C0065, (01)10801902172867(17)260228(10)18F24C0067, (01)10801902172867(17)260228(10)18F24C0068, (01)10801902172867(17)260228(10)18F24C0105; c) REF IAB-05850-LWS, UDI: (01)10801902167726(17)240831(10)18F22J0037(13)220927, (01)10801902167726(17)240831(10)18F22J0040(13)220929, (01)10801902167726(17)240930(10)18F22K0044(13)221021, (01)10801902167726(17)240930(10)18F22K0045(13)221021, (01)10801902167726(17)241031(10)18F22K0056(13)221028, (01)10801902167726(17)241031(10)18F22L0012(13)221104, (01)10801902167726(17)250930(10)18F23K0006(13)231031, (01)10801902167726(17)260131(10)18F24B0049(13)240227, (01)10801902167726(17)260228(10)18F24B0075(13)240301, (01)10801902172881(17)250930(10)18F23K0038(13)231028, (01)10801902172881(17)260228(10)18F24C0031(13)240316, (01)10801902172881(17)260228(10)18F24C0032(13)240331, (01)10801902172881(17)260228(10)18F24C0033(13)240315, (01)10801902172881(17)260228(10)18F24C0034(13)240315
  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:
ARROW INTERNATIONAL Inc.
Reason for Recall:
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

Product Codes/Lot Numbers:

a) REF IAB-05830-LWS, UDI: (01)10801902161892(17)241231(10)18F23A0038, (01)10801902161892(17)250131(10)18F23B0023, (01)10801902161892(17)250430(10)18F23D0024, (01)10801902161892(17)250731(10)18F23H0060, (01)10801902161892(17)250930(10)18F23J0075, (01)10801902161892(17)250930(10)18F23K0013, (01)10801902161892(17)251031(10)18F23L0019, (01)10801902161892(17)251031(10)18F23L0041, (01)10801902161892(17)260131(10)18F24B0008, (01)10801902161892(17)260228(10)18F24C0058, (01)10801902161892(17)260228(10)18F24C0101, (01)10801902161892(17)260331(10)18F24D0002, (01)10801902172843(17)250228(10)18F23C0026, (01)10801902172843(17)250531(10)18F23F0049, (01)10801902172843(17)250831(10)18F23J0001, (01)10801902172843(17)251031(10)18F23L0054, (01)10801902172843(17)251130(10)18F23M0056, (01)10801902172843(17)251231(10)18F24A0015, (01)10801902172843(17)260131(10)18F24A0040, (01)10801902172843(17)260131(10)18F24B0013, (01)10801902172843(17)260228(10)18F24C0061, (01)10801902172843(17)260228(10)18F24C0109, (01)10801902172843(17)260228(10)18F24C0110, (01)10801902172843(17)260331(10)18F24C0172, (01)10801902172843(17)260331(10)18F24C0173, (01)10801902172843(17)46112(10)18F24C0088, (01)10801902172843(17)46112(10)18F24C0089, (01)10801902172843(17)46112(10)18F24C0174, (01)10801902172843(17)46112(10)18F24C0175, (01)10801902172843(17)46112(10)18F24C0176, (01)10801902172843(17)46112(10)18F24C0185; b) REF IAB-05840-LWS, UDI: (01)10801902167733(17)240531(10)18F22F0072, (01)10801902167733(17)240630(10)18F22G0021, (01)10801902167733(17)240630(10)18F22G0031, (01)10801902167733(17)240630(10)18F22G0046, (01)10801902167733(17)240731(10)18F22H0009, (01)10801902167733(17)240731(10)18F22H0023, (01)10801902167733(17)240731(10)18F22H0058, (01)10801902167733(17)240930(10)18F22K0015, (01)10801902167733(17)241130(10)18F22M0017, (01)10801902167733(17)241130(10)18F22M0018, (01)10801902167733(17)241231(10)18F23A0004, (01)10801902167733(17)241231(10)18F23A0005, (01)10801902167733(17)241231(10)18F23A0018, (01)10801902167733(17)241231(10)18F23A0026, (01)10801902167733(17)250131(10)18F23B0008, (01)10801902167733(17)250131(10)18F23B0016, (01)10801902167733(17)250531(10)18F23E0054, (01)10801902167733(17)250630(10)18F23G0017, (01)10801902167733(17)250731(10)18F23H0029, (01)10801902167733(17)250731(10)18F23H0064, (01)10801902167733(17)251031(10)18F23L0009, (01)10801902167733(17)251031(10)18F23L0028, (01)10801902167733(17)251231(10)18F23M0068, (01)10801902167733(17)251231(10)18F24A0030, (01)10801902167733(17)251231(10)18F24A0039, (01)10801902167733(17)260131(10)18F24B0015, (01)10801902167733(17)260131(10)18F24B0031, (01)10801902167733(17)260228(10)18F24C0008, (01)10801902167733(17)260228(10)18F24C0069, (01)10801902167733(17)260228(10)18F24C0071, (01)10801902167733(17)260228(10)18F24C0072, (01)10801902167733(17)260228(10)18F24C0075, (01)10801902167733(17)260228(10)18F24C0076, (01)10801902167733(17)260228(10)18F24C0077, (01)10801902167733(17)260228(10)18F24C0078, (01)10801902167733(17)260228(10)18F24C0079, (01)10801902167733(17)260228(10)18F24C0080, (01)10801902167733(17)260228(10)18F24C0081, (01)10801902167733(17)260331(10)18F24C0083, (01)10801902167733(17)260331(10)18F24C0186, (01)10801902167733(17)260331(10)18F24C0187, (01)10801902167733(17)260331(10)18F24C0188, (01)10801902167733(17)260331(10)18F24C0193, (01)10801902167733(17)260331(10)18F24D0020, (01)10801902167733(17)260331(10)18F24D0021, (01)10801902167733(17)260331(10)18F24D0022, (01)10801902167733(17)260331(10)18F24D0031, (01)10801902167733(17)260331(10)18F24D0032, (01)10801902167733(17)260331(10)18F24D0037, (01)10801902167733(17)260331(10)18F24D0038, (01)10801902167733(17)260331(10)18F24D0039, (01)10801902167733(17)260331(10)18F24D0042, (01)10801902167733(17)260331(10)18F24D0044, (01)10801902167733(17)260331(10)18F24D0045, (01)10801902167733(17)260331(10)18F24D0049, (01)10801902167733(17)260331(10)18F24D0050, (01)10801902167733(17)260331(10)18F24D0051, (01)10801902167733(17)260331(10)18F24D0054, (01)10801902167733(17)260331(10)18F24D0055, (01)10801902167733(17)260331(10)18F24D0072, (01)10801902167733(17)260331(10)18F24D0087, (01)10801902167733(17)260331(10)18F24D0088, (01)10801902167733(17)260331(10)18F24D0089, (01)10801902167733(17)260331(10)18F24D0090, (01)10801902167733(17)260331(10)18F24D0091, (01)10801902167733(17)260331(10)18F24D0092, (01)10801902172867(17)240430(10)18F22E0008, (01)10801902172867(17)240430(10)18F22E0029, (01)10801902172867(17)240531(10)18F22F0006, (01)10801902172867(17)240531(10)18F22F0018, (01)10801902172867(17)240531(10)18F22F0039, (01)10801902172867(17)240630(10)18F22G0002, (01)10801902172867(17)240630(10)18F22G0003, (01)10801902172867(17)240630(10)18F22G0019, (01)10801902172867(17)240630(10)18F22G0059, (01)10801902172867(17)240731(10)18F22H0035, (01)10801902172867(17)240831(10)18F22J0025, (01)10801902172867(17)240930(10)18F22K0016, (01)10801902172867(17)250430(10)18F23E0020, (01)10801902172867(17)250531(10)18F23F0002, (01)10801902172867(17)250531(10)18F23F0026, (01)10801902172867(17)250630(10)18F23G0008, (01)10801902172867(17)250731(10)18F23G0057, (01)10801902172867(17)250731(10)18F23H0013, (01)10801902172867(17)250731(10)18F23H0055, (01)10801902172867(17)250831(10)18F23J0003, (01)10801902172867(17)250831(10)18F23J0037, (01)10801902172867(17)250831(10)18F23J0072, (01)10801902172867(17)250930(10)18F23J0073, (01)10801902172867(17)251031(10)18F23K0054, (01)10801902172867(17)251130(10)18F23L0055, (01)10801902172867(17)251130(10)18F23M0043, (01)10801902172867(17)251231(10)18F24A0025, (01)10801902172867(17)251231(10)18F24A0031, (01)10801902172867(17)260131(10)18F24B0005, (01)10801902172867(17)260131(10)18F24B0048, (01)10801902172867(17)260131(10)18F24B0052, (01)10801902172867(17)260228(10)18F24B0078, (01)10801902172867(17)260228(10)18F24C0036, (01)10801902172867(17)260228(10)18F24C0064, (01)10801902172867(17)260228(10)18F24C0065, (01)10801902172867(17)260228(10)18F24C0067, (01)10801902172867(17)260228(10)18F24C0068, (01)10801902172867(17)260228(10)18F24C0105; c) REF IAB-05850-LWS, UDI: (01)10801902167726(17)240831(10)18F22J0037(13)220927, (01)10801902167726(17)240831(10)18F22J0040(13)220929, (01)10801902167726(17)240930(10)18F22K0044(13)221021, (01)10801902167726(17)240930(10)18F22K0045(13)221021, (01)10801902167726(17)241031(10)18F22K0056(13)221028, (01)10801902167726(17)241031(10)18F22L0012(13)221104, (01)10801902167726(17)250930(10)18F23K0006(13)231031, (01)10801902167726(17)260131(10)18F24B0049(13)240227, (01)10801902167726(17)260228(10)18F24B0075(13)240301, (01)10801902172881(17)250930(10)18F23K0038(13)231028, (01)10801902172881(17)260228(10)18F24C0031(13)240316, (01)10801902172881(17)260228(10)18F24C0032(13)240331, (01)10801902172881(17)260228(10)18F24C0033(13)240315, (01)10801902172881(17)260228(10)18F24C0034(13)240315

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1878-2024

Related Recalls

Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.

ARROW INTERNATIONAL

Class I - Dangerous

Reports have been received regarding open seals on the packaging.

Jul 26, 2024 Surgical Instruments Nationwide View Details →

Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U

ARROW INTERNATIONAL

Class I - Dangerous

Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

Apr 29, 2024 Surgical Instruments Nationwide View Details →

Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U

ARROW INTERNATIONAL

Class I - Dangerous

Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

Apr 29, 2024 Surgical Instruments Nationwide View Details →