Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit Recalled by ARROW INTERNATIONAL Inc. Due to Teleflex received reports indicating an infrequent condition that,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ARROW INTERNATIONAL Inc. directly.
Affected Products
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Quantity: 3138 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ARROW INTERNATIONAL Inc.
ARROW INTERNATIONAL Inc. has 47 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report