HANCOCK® II T510C25 (UDI 00643169594449)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169594449), received between Apr 22, 2020 and Jun 12, 2026 — classified as 1 death, 2 injuries.

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

4 other recalls cover devices cleared under the same FDA submission (P980043); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• InjuryJun 12, 2026Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION ARREST. IT WAS FURTHER NOTED THAT ONE DAY LATER, STERNAL REENTRY WAS PREFORMED DUE TO MEDIASTINAL BLEEDING AND THE PATIENT WAS STARTED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). IT WAS ALSO REPORTED THAT THE BLEEDING WAS REPAIRED AND THE PATIENT HAD CEREBROVASCULAR ACCIDENT (CVA). HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ONE DAY LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Stroke/CVA; Ventricular Fibrillation

  MAUDE report 25487574 ↗
• InjuryApr 29, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 9 MONTHS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 25026637 ↗
• DeathApr 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS PATIENT UNDERWENT MITRAL VALVE REPLACEMENT DUE TO SEVERE MITRAL REGURGITATION. AT THE TIME OF ADMISSION TO THE HOSPITAL, IT WAS REPORTED THAT THE PATIENT WAS COAGULOPATHIC. THE PATIENT'S MITRAL ANNULUS WAS EXTENSIVELY CALCIFIED AND WAS DEBRIDED. FOLLOWING THE DECALCIFICATION, A RIDGE OF CALCIUM REMAINED ON THE ANNULUS. THE CALCIFIED PORTION OF THE ANNULUS WAS COVERED WITH A STRIP OF BOVINE PERICARDIUM PRIOR TO IMPLANTING THIS BIOPROSTHETIC MITRAL VALVE. THE VALVE WAS SUCCESSFULLY IMPLANTED WITH NO REGURGITATION OR BLEEDING NOTED. FOLLOWING MITRAL VALVE REPLACEMENT, THE PATIENT'S TRICUSPID VALVE WAS REPAIRED WITH A NON-MEDTRONIC ANNULOPLASTY RING. TEMPORARY PACING WIRES WERE INSERTED IN THE LEFT AND RIGHT ATRIAL APPENDAGES AND THE RIGHT VENTRICLE. WHILE ATTEMPTING TO REMOVE THIS PATIENT FROM CARDIOPULMONARY BYPASS (CPB), BLEEDING WAS NOTED BEHIND THE HEART. IT WAS REPORTED THAT THE BLEEDING WAS COMING THE UNION OF THE LEFT ATRIAL APPENDAGE AND THE LEFT ATRIUM. THE LESION WAS ATTEMPTED TO BE REPAIRED FOR SEVERAL HOURS. IT WAS REPORTED THAT SPONTANEOUS DEHISCENCE OF THE CRUX OF THE HEART OCCURRED. ULTIMATELY THE PATIENT EXPIRED IN THE OPERATING

  Patient problems: Calcium Deposits/Calcification; Death; Exsanguination; Rupture

  MAUDE report 9985427 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P980043. One submission often covers many models, so check the product and lot details in each record.

• Z-1883-2019 · May 21, 2019 · Terminated
  Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
• Z-1882-2019 · May 21, 2019 · Terminated
  Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
• Z-1884-2019 · May 21, 2019 · Terminated
  Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
• Z-1226-2009 · Jan 26, 2009 · Terminated
  Hancock II Bioprostheses with Cinch, Heart Valve, Model # T505 & T510; Catalog #s T505C2501, T505C2101, T505U25ID , T505C2301, T505C2301, T505C2501, T505C2101, T510C29ID, T510C25ID