Arrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect

Plain-English summary

Arrow International has recalled the Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter Kit, a critical device used to support cardiac patients. The recall affects two reference models (REF IAB-05830-U and REF IAB-05840-U), totaling 3,138 units distributed worldwide, including across the United States and 48 other countries.

The devices may have a defect that prevents the intra-aortic balloon from inflating completely along its full length, or that causes damage or breaks in the central lumen (the channel through which helium flows). Additionally, there is a risk of helium loss or blood entering the helium pathway. When not promptly identified and corrected, these defects could result in serious health consequences.

Patients who have received this device and healthcare providers using or holding inventory should immediately stop using the affected units. Healthcare providers should contact Arrow International for device replacement and instructions on how to proceed with patients who have already received the device. The affected lot numbers are specified by the UDI codes listed in the FDA recall notice.

The recalled product

Product

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

Manufacturer

ARROW INTERNATIONAL Inc.

Category

Medical Device — Cardiac Support / Intra-Aortic Balloon

Hazard

• balloon-inflation-failure
• lumen-damage
• helium-compromise

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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