HANCOCK® II T510C31 (UDI 00643169027121)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169027121), received between May 16, 2017 and Nov 26, 2025 — classified as 1 death, 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 9 YEARS AND 8 MONTHS POST IMPLANT OF THIS 31MM AORTIC BIOPROSTHETIC VALVE, A 23MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23656124 ↗
• InjuryNov 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 15 DAYS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS UNSPECIFIED ATRIOVENTRICULAR (AV BLOCK). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 18049731 ↗
• InjuryDec 1, 2022Adverse 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 31MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS VALVE DISEASE AND INCOMPLETE ATRIO-VENTRICULAR BLOCK (AVB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 15896675 ↗
• InjuryAug 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 7 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 15317523 ↗
• InjuryJun 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 7 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM NON-MEDTRONIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14699330 ↗
• InjurySep 20, 2021Calcified; Incomplete Coaptation; Insufficient Device Problem Information; Calcified; Incomplete Coaptation; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 31MM BIOPROSTHETIC MITRAL VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body Reaction; Insufficient Information

  MAUDE report 12501953 ↗
• InjuryOct 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 7 MONTHS POST IMPLANT OF THIS 31MM BIOPROSTHETIC MITRAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10720643 ↗
• InjurySep 25, 2020Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 6 YEARS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS A "LEAK" THAT RESULTED IN DIFFICULTY BREATHING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Insufficiency, Valvular

  MAUDE report 10590080 ↗
• InjuryJun 12, 2020Adverse 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 APPROXIMATELY 4 YEARS AND 4 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 33MM BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; No Information

  MAUDE report 10148419 ↗
• InjuryOct 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7926735 ↗
• DeathJul 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ON THE DAY OF IMPLANT OF THIS MITRAL BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH IS UNKNOWN. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Death

  MAUDE report 6755475 ↗
• InjuryMay 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE PATIENT DEVELOPED COMPLETE HEART BLOCK REQUIRING THE IMPLANT OF A PERMANENT PACEMAKER. PREOPERATIVE ELECTROCARDIOGRAM (ECG) ALSO REVEALED UNDERLYING SINUS BRADYCARDIA WITH COMPLETE ATRIO-VENTRICULAR (AV) BLOCK, LEFT BUNDLE BRANCH BLOCK (LBBB) AND RIGHT BUNDLE BRANCH BLOCK (RBBB) NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. RELEVANT MEDICAL HISTORY INCLUDES: MITRAL REGURGITATION, AORTIC REGURGITATION, TRICUSPID REGURGITATION, LEAFLET PROLAPSE.

  Patient problems: Complete Heart Block; Non specific EKG/ECG Changes

  MAUDE report 6579126 ↗
• InjuryMay 16, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT AN UNKNOWN DURATION POST IMPLANT OF THIS TRICUSPID BIOPROSTHETIC VALVE, THE PATIENT REPORTED PAIN AND DIFFICULTY WALKING. THE PATIENT'S DEVICE MAY HAVE BEEN REPLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 6569196 ↗

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-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-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-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