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EDWARDS BALLOON CATHETER
Edwards Lifesciences LLC · Model 9350BC16 · UDI-DI 00690103194333
10
510(k) clearances
388
Adverse events (35 deaths)
2
Recalls
24
Facilities
Description
EDWARDS BALLOON CATHETER
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.