Edwards Commander M Delivery System 9880CM29ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103219777), received between May 21, 2026 and May 21, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Inflation Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Inflation Problem

  EDWARDS RECEIVED NOTIFICATION OF A SAPIEN M3 PROCEDURE IN THE MITRAL POSITION IN WHICH DURING VALVE DEPLOYMENT, THE PATIENT EXPERIENCED HYPOTENSION FOLLOWING BALLOON INFLATION, REQUIRING ADMINISTRATION OF EPINEPHRINE. THE PATIENT STABILIZED AFTER INTERVENTION, WITH NO LASTING CLINICAL EFFECTS REPORTED.

  Patient problems: Hemodynamic instability

  MAUDE report 25250224 ↗