HANCOCK® II T510C31 (UDI 00643169594425)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169594425), received between Sep 20, 2018 and May 27, 2026 — classified as 1 death, 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 FDA recall record name this device's identifier.

3 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.

Recalls naming this device

1. May 21, 2019Terminated

   Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.

   Z-1884-2019 · Root cause: Labeling mix-ups · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 8 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE OF A NEW MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25301412 ↗
• InjuryApr 29, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 31MM HANCOCK VALVE IMPLANTED IN THE TRICUSPID POSITION ON THE SAME DAY, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB) AND VALVE DISEASE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 25026531 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 7 YEARS AND 7 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED IN THE SAME POSITION WITH A 33MM MITRAL BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24625851 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 8 YEARS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN VAL VE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24529870 ↗
• InjuryOct 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 13 DAYS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS SUDDEN CARDIAC ARREST AND ATRIAL ARRHYTHMIAS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia; Cardiac Arrest

  MAUDE report 23280031 ↗
• InjurySep 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 10 MONTHS POST IMPLANT OF THIS HANCOCK II VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS LOW EJECTION FRACTION (EF). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Non specific EKG/ECG Changes

  MAUDE report 23005574 ↗
• InjuryJul 21, 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, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED TO BE DUE TO COMPLETE HEART BLOCK. IT WAS STATED THAT THE PHYSICIAN BELIEVES THAT THE HEART BLOCK WAS A DIRECT RESULT OF THE OPEN HEART VALVE IMPLANT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 15074819 ↗
• InjurySep 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 2 MONTHS POST IMPLANT OF THIS 31MM TRICUSPID BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 33MM TRICUSPID BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10497651 ↗
• InjuryJul 24, 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 7 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED WITH A VALVE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; No Information

  MAUDE report 10320102 ↗
• InjurySep 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 3.5 MONTHS POST IMPLANT OF THIS MITRAL BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A VALVE OF THE SAME SIZE AND MODEL.  THE REASON FOR THE EXPLANT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9075572 ↗
• InjuryMay 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 31 MM BIOPROSTHETIC VALVE IN THE TRICUSPID POSITION, THE PATIENT EXPERIENCED A COMPLETE HEART BLOCK THAT REQUIRED THE IMPLANTATION OF A PERMANENT PACEMAKER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 8620570 ↗
• DeathSep 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR EXPLANT WAS NOT REPORTED. SUBSEQUENTLY, 6 DAYS POST IMPLANT OF THE BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THERE WAS NO EVIDENCE TO SUGGEST THAT THE VALVE OR ITS FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Cardiomyopathy; Death

  MAUDE report 7895521 ↗

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-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