Device product
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Z-1064-2013
Product summary
- Event
- Event 64527
- Status
- Terminated
- Classification
- Class II
- Quantity
- 188 units
- Official record key
device-enforcement:Z-1064-2013
Official wording
Reason: Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
Code information: Lot Numbers: KF2073734 KS2083999 KF2083869 KF2083921
Distribution pattern: Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.
Derived failure modes
-
Unknown
Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.