Severe FDA (Devices)·Z-1878-2024·Announced 2024-06-12

Intra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects

Arrow International is recalling intra-aortic balloon catheter kits due to potential inflation failure, catheter damage, and helium loss that could cause serious health consequences.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification indicates reasonable probability of serious adverse health consequences. No deaths or reported illnesses were stated, but the potential for device malfunction in critical cardiac care warrants severity score 4.

Plain-English summary

Arrow International is recalling its FiberOptix Intra-Aortic Balloon Catheter Kit in three models (REF IAB-05830-LWS, REF IAB-05840-LWS, and REF IAB-05850-LWS). Approximately 7,939 affected units were distributed worldwide to healthcare facilities in the United States, Puerto Rico, and numerous international locations.

The devices may fail to inflate completely along their full length, or may exhibit damage or breaks in the central lumen within the balloon. Users may also experience helium loss or blood intrusion into the helium pathway. These defects, when not identified and corrected promptly, could result in serious health consequences.

Healthcare facilities should immediately cease use of affected devices and contact Arrow International for instructions on replacement or return.

The recalled product

Product: Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
Manufacturer: ARROW INTERNATIONAL Inc.
Category: Medical Device — Intra-aortic Balloon Catheter
Hazard: balloon-inflation-failure
catheter-damage
gas-leakage
contamination
Affected units: 7,939

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 3 recalled by ARROW INTERNATIONAL Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · ARROW INTERNATIONAL Inc.

See all →

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Same hazard · balloon inflation failure