InterValve V8 Balloon Aortic Valvuloplasty Catheter — Class II medical device recall Z-1621-2014
Terminated recall by InterValve Inc, reported 2014-05-21, distributed in TN. Leak issues were discovered through accelerated age testing.
| Recall number | Z-1621-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | InterValve Inc, Minnetonka, MN, United States |
| Recall initiated | 2014-03-14 |
| Classified | 2014-05-15 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2014-06-16 |
| Distributed | TN |
| Quantity | 2 |
| Reason classes | packaging |
| Lot numbers | 101637, 101640 |
| Model numbers | 172212C110, 192412C110, 212612C110, 232812C110 |
Product
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Reason for recall
Leak issues were discovered through accelerated age testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1621-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.