HANCOCK® II T510C29 (UDI 00643169594418)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169594418), received between Dec 18, 2017 and Nov 24, 2025 — classified as 1 death, 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Intravalvular regurgitation; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS SEVERE MITRAL REGURGITATION. NO ADDITIONAL ADVERSE P ATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23639585 ↗
• InjuryNov 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR PACEMAKER IMPLANT AS 2ND DEGREE ATRIOVENTRICULAR BLOCK WITH IRREVERSIBLE BRADYCARDIA AND ATRIAL FIBRILLATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Bradycardia; Cardiac Arrest; Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 20641140 ↗
• InjurySep 25, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE CINCH SUTURES BROKE DUE TO OVER RATCHETING OF THE HOLDER. A SECOND 29MM VALVE OF THE SAME MODEL WAS USED, AND THE CINCH SUTURE ALSO BROKE ON THIS DEVICE DUE TO OVER CINCHING OF THE VALVE. IT IS UNKNOWN WHAT DEVICE WAS ULTIMATELY IMPLANTED IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20302445 ↗
• InjurySep 25, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE CINCH SUTURES BROKE DUE TO OVER RATCHETING OF THE HOLDER. A SECOND 29MM VALVE OF THE SAME MODEL WAS USED, AND THE CINCH SUTURE ALSO BROKE ON THIS DEVICE DUE TO OVER CINCHING OF THE VALVE. IT IS UNKNOWN WHAT DEVICE WAS ULTIMATELY IMPLANTED IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20302429 ↗
• InjuryMay 31, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED WITH A 33MM BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 11906084 ↗
• InjuryMar 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 22 DAYS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 33MM BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11561602 ↗
• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF THIS 29MM BIOPROSTHETIC MITRAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT. THE REASON FOR THE PACEMAKER IMPLANT WAS REPORTED AS INCOMPLETE ATRIO-VENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 11366844 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 29MM BIOPROSTHETIC MITRAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT. THE REASON FOR THE PERMANENT PACEMAKER IMPLANT WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 9335519 ↗
• InjuryJan 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 29MM MITRAL BIOPROSTHETIC VALVE WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE DEVICE WAS REPLACED WITH A 27MM BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8220654 ↗
• DeathSep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS REPORTED AS "CARDIOGENIC SHOCK FOLLOWING COMPLEX CARDIAC SURGERY, WITH POOR CORONARY ARTERY DISEASE, ISCHEMIC CARDIOMYOPATHY, MITRAL VALVE REGURGITATION OF MIXED ETIOLOGY, AND CHRONIC ATRIAL FIBRILLATION WITH MULTIPLE ADDITIONAL COMORBIDITIES". THE SURGEON INDICATED THAT THE VALVE AND ITS FUNCTION DID NOT CONTRIBUTE TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Death

  MAUDE report 7846365 ↗
• InjuryDec 18, 2017Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A LOWER PROFILE MECHANICAL VALVE DUE TO BLOOD FLOW BEING BLOCKED BY THE BIOPROSTHETIC VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7126272 ↗

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