🔍 RecallPedia

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

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-U, UDI: (01)10801902172850(17)240531(10)18F22F0023, (01)10801902172850(17)240630(10)18F22G0005, (01)10801902172850(17)240630(10)18F22G0010, (01)10801902172850(17)240731(10)18F22H0033, (01)10801902172850(17)250831(10)18F23J0031, (01)10801902172850(17)250930(10)18F23K0036, (01)10801902172850(17)250930(10)18F23K0042, (01)10801902172850(17)251130(10)18F23M0001, (01)10801902182019(17)250430(10)18F23E0032, (01)10801902182019(17)250831(10)18F23J0002, (01)10801902182019(17)250831(10)18F23J0082, (01)10801902182019(17)250930(10)18F23K0025, (01)10801902182019(17)260331(10)18F24C0131; b) REF IAB-05840-U, UDI: (01)10801902161922(17)240630(10)18F22G0051, (01)10801902161922(17)241231(10)18F23A0002, (01)10801902161922(17)241231(10)18F23A0021, (01)10801902161922(17)241231(10)18F23A0060, (01)10801902161922(17)250731(10)18F23G0068, (01)10801902161922(17)250930(10)18F23K0012, (01)10801902161922(17)251031(10)18F23K0053, (01)10801902161922(17)251031(10)18F23K0063, (01)10801902161922(17)260131(10)18F24B0051, (01)10801902172874(17)240430(10)18F22E0012, (01)10801902172874(17)240630(10)18F22G0011, (01)10801902172874(17)240630(10)18F22G0016, (01)10801902172874(17)250930(10)18F23K0039, (01)10801902172874(17)251031(10)18F23L0010, (01)10801902172874(17)251031(10)18F23L0031, (01)10801902172874(17)251031(10)18F23L0039, (01)10801902172874(17)251130(10)18F23K0008
  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 Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U

Product Codes/Lot Numbers:

a) REF IAB-05830-U, UDI: (01)10801902172850(17)240531(10)18F22F0023, (01)10801902172850(17)240630(10)18F22G0005, (01)10801902172850(17)240630(10)18F22G0010, (01)10801902172850(17)240731(10)18F22H0033, (01)10801902172850(17)250831(10)18F23J0031, (01)10801902172850(17)250930(10)18F23K0036, (01)10801902172850(17)250930(10)18F23K0042, (01)10801902172850(17)251130(10)18F23M0001, (01)10801902182019(17)250430(10)18F23E0032, (01)10801902182019(17)250831(10)18F23J0002, (01)10801902182019(17)250831(10)18F23J0082, (01)10801902182019(17)250930(10)18F23K0025, (01)10801902182019(17)260331(10)18F24C0131; b) REF IAB-05840-U, UDI: (01)10801902161922(17)240630(10)18F22G0051, (01)10801902161922(17)241231(10)18F23A0002, (01)10801902161922(17)241231(10)18F23A0021, (01)10801902161922(17)241231(10)18F23A0060, (01)10801902161922(17)250731(10)18F23G0068, (01)10801902161922(17)250930(10)18F23K0012, (01)10801902161922(17)251031(10)18F23K0053, (01)10801902161922(17)251031(10)18F23K0063, (01)10801902161922(17)260131(10)18F24B0051, (01)10801902172874(17)240430(10)18F22E0012, (01)10801902172874(17)240630(10)18F22G0011, (01)10801902172874(17)240630(10)18F22G0016, (01)10801902172874(17)250930(10)18F23K0039, (01)10801902172874(17)251031(10)18F23L0010, (01)10801902172874(17)251031(10)18F23L0031, (01)10801902172874(17)251031(10)18F23L0039, (01)10801902172874(17)251130(10)18F23K0008

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1880-2024

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

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 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 →