CARBOMEDICS REDUCED R5-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08022057012784), received between Nov 24, 2016 and Jul 13, 2023 — classified as 2 deaths, 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2023Break; Break

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023 A PATIENT UNDERWENT AORTIC VALVE REPLACEMENT WITH CARBOMEDICS REDUCED SIZE 23 MECHANICAL PROSTHESIS AND REPLACEMENT OF THE ASCENDING AORTA FOR THE TREATMENT OF AORTIC STENOSIS AND DILATATION OF THE AORTA. PATIENT'S NATIVE AORTIC VALVE WAS BICUSPID. AS REPORTED, WHILE APPLYING TRACTION ON THE MECHANICAL PROSTHESIS TO ADD A SUTURE AT THE END OF THE PROCEDURE, A BREAKING OF ONE OF THE LEAFLETS OCCURRED WHICH REQUIRED THE PROCEDURE TO BE REPEATED WITH A NEW PROSTHESIS. ANOTHER CARBOMEDICS REDUCED VALVE WAS CHOSEN AS REPLACEMENT DEVICE. WHILE RESTORING CARDIAC FUNCTION, THE PATIENT EXPERIENCED RECURRENT VENTRICULAR FIBRILLATION WHICH REQUIRED INFUSION OF CORDARONE 300 MG AND MAGNESIUM 2 G, RESUMPTION OF BYPASS SURGERY AND A NEW CARDIOPLEGIA. FINALLY, CARDIAC FUNCTION WAS SUCCESSFULLY RESTORED WITH EXTERNAL PACING AND NORADRENALINE 2MG/H. REPORTEDLY, THE PATIENT EXPERIENCED FRAGILITY OF THE NATIVE ANNULUS, CONDUCTIVE DISORDERS (BAV III WITH ESCAPE RHYTHM AT 50 BPM) AND CLAMPING TIME PROLONGATION (CEC TIME 146 MIN/AORTIC CLAMP TIME 120 MIN). DUE TO PERSISTENCE OF THE CONDUCTION DISTURBANCE POST-OPERATIVELY (BAV III DEGREE WITH AFIB) THE PA

  Patient problems: Insufficient Information

  MAUDE report 17314743 ↗
• DeathMay 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE RETRO STUDY 'A CLINICAL FOLLOW-UP AND STATISTICAL ANALYSIS TO EVALUATE THE MID- AND LONG-TERM SAFETY OF ARTIFICIAL HEART VALVE IMPLANTATION IN HUMANS'. THE RESULTS OF THIS RETROSPECTIVE FOLLOW-UP SHOWED THAT THE CPHV-R5, M7 ARTIFICIAL HEART VALVE HAS A LOW INCIDENCE OF RELATED CLINICAL EVENTS AFTER IMPLANTATION IN HUMANS, AND HAS NO UNEXPECTED ADVERSE EVENTS. IN ADDITION, IT HAS GOOD MID- AND LONG-TERM SAFETY. AMONG THE RESULTS PRESENTED IN THIS STUDY, IT IS REPORTED THAT ONE PATIENT HAD A VALVE-RELATED DEATH EVENT. THE PATIENT RECEIVED AN R5-023 ON (B)(6) 2018. AFTER THE PROCEDURE, BLOOD TRANSFUSION WAS PERFORMED WITH LESS PLASMA 2U, PLASMA 400ML, POSTOPERATIVE FLUID REHYDRATION, AND OTHER SUPPORTIVE TREATMENTS. CARDIAC ARREST OCCURRED IN THE EARLY MORNING OF THE FIRST DAY AFTER SURGERY, AND NO IMPROVEMENT WAS FOUND AFTER CARDIOPULMONARY RESUSCITATION. THE PATIENT PASSED AWAY FOR CARDIAC DEATH ON (B)(6) 2018. GOOD DEVICE FUNCTIONALITY IS REPORTED, NO MALFUNCTIONS WERE RECORDED. THE PATIENT HAS A MEDICAL HISTORY OF HYPERTENSION FOR 4 YEARS AND A HISTORY OF SMOKING AND DRINKING (HAS GIVEN UP). THE PATIENT HAD DIZZINESS ACCOMPAN

  Patient problems: Death

  MAUDE report 10094608 ↗
• DeathMay 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE RETRO STUDY 'A CLINICAL FOLLOW-UP AND STATISTICAL ANALYSIS TO EVALUATE THE MID- AND LONG-TERM SAFETY OF ARTIFICIAL HEART VALVE IMPLANTATION IN HUMANS'. THE RESULTS OF THIS RETROSPECTIVE FOLLOW-UP SHOWED THAT THE CPHV-R5, M7 ARTIFICIAL HEART VALVE HAS A LOW INCIDENCE OF RELATED CLINICAL EVENTS AFTER IMPLANTATION IN HUMANS, AND HAS NO UNEXPECTED ADVERSE EVENTS. IN ADDITION, IT HAS GOOD MID- AND LONG-TERM SAFETY. AMONG THE RESULTS PRESENTED IN THIS STUDY, IT IS REPORTED THAT ONE PATIENT HAD A VALVE-RELATED DEATH EVENT. THE PATIENT RECEIVED AN R5-023 ON (B)(6) 2018 AND REPORTEDLY PASSED AWAY ON (B)(6) 2018. THE STUDY DOES NOT FURTHER SPECIFY THE TYPE OF DEATH NOR HOW THE DEVICE IS THOUGHT TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. FURTHERMORE, NO EVENTS OF VALVE DYSFUNCTION (INCLUDING VALVE STRUCTURE DEGRADATION AND NON-STRUCTURAL VALVE DYSFUNCTION) OCCURRED PER THE STUDY RESULTS, AND THAT NO PATIENT HAD A RE-INTERVENTION CAUSED BY VALVE PROBLEMS. THE PATIENT HAS A MEDICAL HISTORY OF HYPERTENSION FOR 4 YEARS AND A HISTORY OF SMOKING AND DRINKING (HAS GIVEN UP). THE PATIENT HAD DIZZINESS ACCOMPANIED BY AMAUROSIS FOR MORE THAN 1 YE

  Patient problems: Death

  MAUDE report 10094383 ↗
• InjuryJan 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018 A PATIENT RECEIVED A CARBOMEDICS REDUCED R5-023 AS PART OF THE SURE-AVR TRIAL. THE MANUFACTURER WAS NOTIFIED OF A SERIOUS ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2019. THE PATIENT RECEIVED A REINTERVENTION DUE TO VALVE ENDOCARDITIS. THE DEVICE WAS EXPLANTED. NO REPLACEMENT VALVE WAS IDENTIFIED. NO FURTHER EVENT INFORMATION OR PATIENT INFORMATION WAS RECEIVED.

  Patient problems: Endocarditis

  MAUDE report 9597277 ↗
• InjuryJan 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018 A PATIENT RECEIVED A CARBOMEDICS REDUCED R5-023 AS PART OF THE SURE-AVR TRIAL. THE MANUFACTURER WAS NOTIFIED OF A SERIOUS ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2019. THE PATIENT RECEIVED A REINTERVENTION DUE TO VALVE ENDOCARDITIS. THE DEVICE WAS EXPLANTED. NO REPLACEMENT VALVE WAS IDENTIFIED. NO FURTHER EVENT INFORMATION OR PATIENT INFORMATION WAS RECEIVED.

  Patient problems: Endocarditis

  MAUDE report 9597240 ↗
• InjuryFeb 25, 2019No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  A CARBOMEDICS REDUCED AORTIC VALVE WAS REPORTEDLY "USED" BUT NOT IMPLANTED. THE EVENT IS BEING REPORTED IN A CONSERVATIVE MANNER DUE TO UNKNOWN RELATIONSHIP TO THE DEVICE AND UNKNOWN PATIENT IMPACT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 8368705 ↗
• InjuryFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO CARBOMEDICS REDUCED AORTIC VALVE R5-023 IMPLANTED ON (B)(6) 2014. IT WAS EXPLANTED AND REPLACED WITH A SIMILAR DEVICE BUT SMALLER SIZE R5-021 ON (B)(6) 2016. NO FURTHER EVENT DETAILS WERE PROVIDED AND VALVE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 8326433 ↗
• InjuryFeb 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO A CARBOMEDICS REDUCED AORTIC VALVE R5-023, IMPLANTED ON (B)(6) 2014. IT WAS EXPLANTED AND REPLACED WITH ANOTHER SIMILAR VALVE, SAME SIZE R5-023 ON (B)(6) 2014. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Information

  MAUDE report 8318920 ↗
• InjuryOct 12, 2017Inadequate or Insufficient Training; Insufficient Device Problem Information; Inadequate or Insufficient Training; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED THROUGH PATIENT TRACKING OF THE FOLLOWING EVENT: ON (B)(6) 2017, A FAILURE TO IMPLANT OCCURRED. FOLLOWING THIS, AN ATTEMPT WAS MADE TO IMPLANT A CARBOMEDICS REDUCED AORTIC VALVE, R5-23 (SIZE 23) MODEL R500. THE VALVE WAS PLACED UPSIDE-DOWN IN THE MITRAL POSITION, AND WAS SUBSEQUENTLY EXPLANTED. NO INFORMATION IS AVAILABLE REGARDING REPLACEMENT OF THE EXPLANTED DEVICE. THE PATIENT CONCOMITANTLY RECEIVED A TRICUSPID RING. FOLLOW-UP WITH SALES REVEALED THAT THE EVENT OCCURRED DUE TO INADEQUATE PROCTORING REGARDING THE DEVICE IN QUESTION.

  Patient problems: No Information

  MAUDE report 6946115 ↗
• InjuryNov 24, 2016Perivalvular Leak; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Perivalvular Leak; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  INFORMATION FROM PATIENT TRKG ((B)(6) 2016): WE RECEIVED A 2ND PRF FOR PATIENT ((B)(6) MALE, DOB (B)(6) 1969) WHO HAS A R5-023 IMPLANTED IN 2013. DETAILS AS: R5-023 SN # (B)(4) IMPLANTED ON (B)(6) 2013 AT (B)(6) MED CTR (B)(6). R5-025 SN # (B)(4) IMPLANTED ON (B)(6) 2016 AT (B)(6) MED CTR (B)(6).

  Patient problems: Aortic Regurgitation; No Information

  MAUDE report 6126944 ↗