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

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

Is your product affected?

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

Distribution

Distributed nationwide across the United States.

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