FDA Device recall Z-1621-2014
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110
- FDA Device
- Class II
- terminated
- Published 2014-05-21
On 2014-05-21 the FDA classified a Class II recall of InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110 by Intervalve, citing leak issues were discovered through accelerated age testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1621-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-14 |
| Published | 2014-05-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intervalve |
| Distribution | TN |
Product
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Reason
Leak issues were discovered through accelerated age testing.
Identifiers
| code_info | Lot numbers: 101637, 101640 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1621-2014%22
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