InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardi
FDA device recall Z-1621-2014 · posted 2014-05-15 · Terminated
Recall details
- Recalling firm
- InterValve Inc
- Reason for recall
- Leak issues were discovered through accelerated age testing.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OZT
- Quantity affected
- 2
- Distribution
- Distribution to TN only
- Date initiated
- 2014-03-14
- Date posted
- 2014-05-15
- Date terminated
- 2014-06-16
- Location
- Minnetonka, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| V8 TRANSLUMINAL BAV CATHETER (K133607) | Intervalve, Inc. | 2014-02-11 |