Arrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction

Plain-English summary

Arrow International, Inc. is recalling the UltraFlex Intra-Aortic Balloon Catheter Kit (reference numbers IAB-06830-U, IAB-06840-U, and IAB-06850-U). A total of 44,807 units have been distributed worldwide, including throughout the United States and Puerto Rico.

An infrequent condition has been identified in which the intra-aortic balloon may fail to completely inflate along its full length. Alternatively, the device's central lumen may be damaged or broken, or helium may leak from the pathway with blood entering it. These defects could result in serious health consequences if not promptly identified and corrected.

The affected devices have been distributed worldwide to numerous countries. Healthcare providers and patients who have received or used these devices should consult with their physician regarding next steps. Those possessing affected units should contact Arrow International for guidance on replacement or clinical management.

The recalled product

Product

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

Manufacturer

ARROW INTERNATIONAL Inc.

Category

Medical Device — Cardiovascular Device

Hazard

• device-malfunction
• inflation-failure
• internal-damage
• gas-leak

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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