CARBOMEDICS REDUCED R5-029Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08022057012814), received between Oct 13, 2017 and Jan 7, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED THROUGH DEVICE TRACKING ABOUT AN INTRA OPERATIVE EXPLANT OF A CARBOMEDICS REDUCED AORTIC VALVE R5-029 ON (B)(6) 2025. FURTHER INFORMATION CONFIRMED THAT VALVE WAS EXPLANTED INTRAOPERATIVELY. THE VALVE WAS EXPLANTED AS THE PATIENT UNDERWENT A HEART TRANSPLANT INSTEAD. NO DEVICE MALFUNCTION WAS IDENTIFIED. PATIENT RECOVERING WELL FOLLOWING HEART TRANSPLANT.

  Patient problems: Insufficient Information

  MAUDE report 23998687 ↗
• InjuryOct 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON SEPTEMBER 14, 2017 THE MANUFACTURER WAS NOTIFIED THROUGH PATIENT TRACKING OF A CARBOMEDICS REDUCED AORTIC VALVE THAT WAS 'WASTED' ON (B)(6) 2017 AND A REPLACEMENT AORTIC ROOT WAS PERFORMED.

  Patient problems: No Information

  MAUDE report 6948034 ↗