HANCOCK® II T510C33 (UDI 00643169594432)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169594432), received between Jan 16, 2018 and Jan 13, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 7 MONTHS POST IMPLANT OF THIS 33MM HANCOCK II AORTIC VALVE, A TRANSCATHETER VALVE FROM ANOTHER MANUFACTURER WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS ENDOCARDITIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis

  MAUDE report 24052589 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUC T. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23642617 ↗
• InjuryOct 21, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, AFTER THE PATIENT WAS WEANED FROM CARDIOPULMONARY B YPASS, IT WAS NOTED THAT THE PATIENT HAD A PARAVALVULAR LEAK IN THE REGION OF THE LEFT FIBROUS TRIGONE. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE OF THE SAME MODEL. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS WITHOUT COMPLICATIONS. NO ADVERSE PATIENT EVENTS WERE REPORTED AS A RESULT OF THIS INTERVENTION.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 23349339 ↗
• InjuryApr 24, 2025Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT POST IMPLANT OF THIS 33MM HANCOCK II VALVE IN THE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED WITH A 31MM HANCOCK II VALVE IN THE TRICUSPID POSITION. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information; Tricuspid Valve Stenosis

  MAUDE report 21901382 ↗
• InjuryNov 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, 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: Insufficient Information

  MAUDE report 20713397 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE REASON FOR REPLACEMENT WAS DUE TO ENDOCARDITIS AND ANNULAR ABSCESS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 17906067 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 33 MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR BLOCK (AVB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 17796683 ↗
• InjurySep 6, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL 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 15362147 ↗
• InjuryMay 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 MONTHS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10038435 ↗
• InjurySep 20, 2019Off-Label Use; Off-Label Use

  MEDTRONIC RECEIVED INFORMATION THAT 9 DAYS POST IMPLANT OF THIS 33MM BIOPROSTHETIC VALVE IN THE TRICUSPID POSITION, 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 9097903 ↗
• InjuryJan 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS POST IMPLANT OF THIS 33MM BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH 31MM BIOPROSTHETIC VALVE OF THE SAME MODEL.  THE REASON FOR THE EXPLANT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; No Information

  MAUDE report 7194200 ↗

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-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-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-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