Device product
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Z-1259-2015
Product summary
- Event
- Event 70603
- Status
- Terminated
- Classification
- Class II
- Quantity
- 166 units
- Official record key
device-enforcement:Z-1259-2015
Official wording
Reason: Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
Code information: Lot Number: KF1111796 Exp. Date: 11/30/2013
Distribution pattern: Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.
Derived failure modes
-
Unknown
Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.