CARBOMEDICS REDUCED R5-019Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08022057012760), received between Nov 6, 2020 and Dec 19, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2023, A CARBOMEDICS REDUCED AORTIC VALVE R5-019 WAS IMPLANTED IN A PATIENT. AS REPORTED, THE "CONDITION WAS NOT GOOD", SO THE VALVE WAS EXPLANTED AND REPLACED WITH A LARGER VALVE R5-023 DURING THE SAME DAY. THE PATIENT IS DOING WELL. BASED ON THE FURTHER INFORMATION RECEIVED, THE PATIENT GOT BETTER AND HAS NO PROBLEM ANYMORE. THE MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18361299 ↗
• InjuryMar 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING. THE TOP HAT SUPPRAANULAR VALVE SIZE 19, WHICH WAS IMPLANTED ON (B)(6) 2013, WAS EXPLANTED ON (B)(6) 2020 DUE TO SEVERE AORTIC STENOSIS AND VALVULAR DISEASE. THE ST. JUDE 21MM VALVE WAS IMPLANTED IN THE PATIENT INSTEAD. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 13772403 ↗
• InjuryNov 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A CARBOMEDICS REDUCED MECHANICAL VALVE R5-019 WAS IMPLANTED ON (B)(6) 2014 AND EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO INDICATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: No Information

  MAUDE report 10805554 ↗
• InjuryNov 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A CARBOMEDICS REDUCED MECHANICAL VALVE R5-019 WAS IMPLANTED ON (B)(6) 2014 AND EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO INDICATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: No Information

  MAUDE report 10805552 ↗