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Edwards Commander M Delivery System
Edwards Lifesciences LLC · Model 9880CM29A · UDI-DI 00690103219777
NPU
Prescription
0
510(k) clearances
2,032
Adverse events (426 deaths)
1
Recalls
18
Facilities
Description
Edwards Commander M Delivery System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-10-05 | Edwards Lifesciences, LLC | Due to a manufacturing issue which may result in cardiovascular balloon rupturing. |
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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.