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HEART VALVE HANDLE ACCESSORY
Edwards Lifesciences LLC · Model 1111 · UDI-DI 00690103019063
10
510(k) clearances
2
Adverse events
1
Recalls
13
Facilities
Description
HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2002-04-30 | Carbomedics, Inc | Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use. |
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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.