Device product
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Z-1621-2014
Product summary
- Firm
- InterValve Inc
- Event
- Event 67964
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1621-2014
Official wording
Reason: Leak issues were discovered through accelerated age testing.
Code information: Lot numbers: 101637, 101640
Distribution pattern: Distribution to TN only
Derived failure modes
-
Unknown
Leak issues were discovered through accelerated age testing.