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V8
INTERVALVE INC · Model V8-2328 · UDI-DI 00859945004136
OZT
Prescription
10
510(k) clearances
367
Adverse events (35 deaths)
2
Recalls
24
Facilities
Description
V8 Balloon Aortic Valvuloplasty Catheter, V8-2328
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-03-14 | InterValve Inc | Leak issues were discovered through accelerated age testing. |
| 2013-03-18 | Loma Vista Medical | Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specificat |
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