Device product
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Z-1065-2013
Product summary
- Event
- Event 64527
- Status
- Terminated
- Classification
- Class II
- Quantity
- 637 units
- Official record key
device-enforcement:Z-1065-2013
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: KF2073694 KF2083874 KF2083966 KF2094179 KF2073788 KF2083927 KF2084059
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.