Device product
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
Z-1233-2015
Product summary
- Event
- Event 70436
- Status
- Terminated
- Classification
- Class II
- Quantity
- 165 units
- Official record key
device-enforcement:Z-1233-2015
Official wording
Reason: Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
Code information: Lot Number: 18F14M0001
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Belgium
Derived failure modes
-
Unknown
Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr