CARBOMEDICS STANDARD A5-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08022057012586), received between Nov 22, 2018 and Mar 24, 2023 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DATABASE. IN THE PATIENT REGISTRATION FORM, IT WAS INDICATED THAT A CARBOMEDICS STANDARD PROSTHETIC AORTIC HEART VALVE, A5-016 WAS ''DISPOSED'' ON 18 AUG 2020. BASED ON THE OPERATIONAL REPORT RECEIVED, AFTER SEVERAL ATTEMPTS TO REPAIR THE LEFT AV VALVE, IT WAS DECIDED THAT THE ORIFICE WAS ALWAYS GOING TO BE TOO SMALL, AND BECAUSE THERE WAS AN EXTENSION OF THE VALVULAR TISSUE WHERE THE COMMISSURE BETWEEN THE SUPERIOR BRIDGING LEAFLET AND MURAL LEAFLET SHOULD HAVE BEEN, IT WAS ELECTED TO REPLACE THE VALVE ON THE LEFT SIDE BECAUSE IT FELT THIS WOULD BE THE ONLY WAY TO ACHIEVE AN ADEQUATE INFLOW, WHICH WOULD REMAIN COMPETENT. THE VALVE WAS EXCISED, AND THEY WERE ABLE TO IMPLANT A 16 MM CARBOMEDICS AORTIC PROSTHESIS IN INVERTED POSITION USING 5-0 PROLENE INTERRUPTED MATTRESS SUTURES. THE VALVE APPEARED TO BE SEATED VERY NICELY, AND BOTH LEAFLETS MOVED FREELY. THE HEART WAS ATTEMPTED TO WEAN FROM BYPASS. THE HEART WAS POOR OFF BYPASS WITH MAINTAINED FUNCTION, BUT POOR CARDIAC OUTPUT. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS OBTAINED. DURING REWARMING, THE VALVE WAS SEEN TO BE OPENING AND CLOSING IN A SYMMETRICAL FA

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16616503 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DATABASE. IN THE PATIENT REGISTRATION FORM, IT WAS INDICATED THAT A CARBOMEDICS STANDARD PROSTHETIC AORTIC HEART VALVE, A5-016 WAS ''DISPOSED'' ON (B)(6) 2020. BASED ON THE OPERATIONAL REPORT RECEIVED, AFTER SEVERAL ATTEMPTS TO REPAIR THE LEFT AV VALVE, IT WAS DECIDED THAT THE ORIFICE WAS ALWAYS GOING TO BE TOO SMALL, AND BECAUSE THERE WAS AN EXTENSION OF THE VALVULAR TISSUE WHERE THE COMMISSURE BETWEEN THE SUPERIOR BRIDGING LEAFLET AND MURAL LEAFLET SHOULD HAVE BEEN, IT WAS ELECTED TO REPLACE THE VALVE ON THE LEFT SIDE BECAUSE IT FELT THIS WOULD BE THE ONLY WAY TO ACHIEVE AN ADEQUATE INFLOW, WHICH WOULD REMAIN COMPETENT. THE VALVE WAS EXCISED, AND THEY WERE ABLE TO IMPLANT A 16 MM CARBOMEDICS AORTIC PROSTHESIS IN INVERTED POSITION USING 5-0 PROLENE INTERRUPTED MATTRESS SUTURES. THE VALVE APPEARED TO BE SEATED VERY NICELY, AND BOTH LEAFLETS MOVED FREELY. THE HEART WAS ATTEMPTED TO WEAN FROM BYPASS. THE HEART WAS POOR OFF BYPASS WITH MAINTAINED FUNCTION, BUT POOR CARDIAC OUTPUT. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS OBTAINED. DURING REWARMING, THE VALVE WAS SEEN TO BE OPENING AND CLOSING IN A SYMMETRICAL FA

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16616386 ↗
• MalfunctionNov 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 A PATIENT RECEIVED A CARBOMEDICS STANDARD A5-016 MECHANICAL HEART VALVE IMPLANT. DURING THE POST-OPERATIVE ECHOCARDIOGRAPHY THE SITE NOTICED A LEAKAGE. THE VALVE WAS EXPLANTED AND REPLACED WITH A R5-019 CARBOMEDICS REDUCED AORTIC VALVE ON (B)(6) 2018.

  Patient problems: No Information

  MAUDE report 8098901 ↗