Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit Recalled by Arrow International Inc Due to Outer package product label incorrectly identifies the product...
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 FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle
Quantity: 165 units
Why Was This Recalled?
Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Arrow International Inc
Arrow International Inc has 431 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report