Recall Z-1621-2014 ยท OZT Balloon Aortic Valvuloplasty
InterValve Inc
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
| Date | May 15, 2014 (initiated Mar 14, 2014) |
| Status | Terminated |
| Reason | Leak issues were discovered through accelerated age testing. |
| Root cause | Nonconforming Material/Component |
| Action | Since this recall involved only 2 units at one site, the devices were picked up by the sales representative. There was no written communication regarding this. The site was verbally informed that there was a problem with the device that manifests itself during prepping and the devices need to be retrieved for retest. |
| Quantity | 2 |
| Distribution | Distribution to TN only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133607 | V8 TRANSLUMINAL BAV CATHETER Intervalve, Inc., Feb 11, 2014 |