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INOUE BALLOON A
TORAY INDUSTRIES,INC. · Model PTAV-26RP · UDI-DI 14960685201433
OZT
Prescription
10
510(k) clearances
367
Adverse events (35 deaths)
2
Recalls
24
Facilities
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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