HANCOCK® II T505C223 (UDI 00643169534049)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169534049), received between Jan 14, 2020 and May 1, 2026 — classified as 1 death, 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• DeathMay 1, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 10 YEARS AND 9 MONTHS POST IMPLANT OF THIS 23 MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT WAS REPORTED DECEASED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE VALVE COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 25056422 ↗
• InjuryFeb 24, 2025Calcified; Gradient Increase; Calcified; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. IT WAS REPORTED THAT CALCIUM WAS SEEN IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) UNDER THE NON-CORONARY CUSP ( NCC). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY 1 DAY LATER, THE PATIENT SUCCESSFULLY HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 21454973 ↗
• InjuryJan 28, 2025Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH GRADIENT GREATER THAN 40 MMHG, AND A TRANSCATHETER AORTIC VALVE IN SURGICAL AORTIC VAL VE PROCEDURE WAS PERFORMED. THE PATIENT HAD A PREVIOUS AORTIC TISSUE VALVE, IDENTIFIED AS HANCOCK II BIOPROSTHESIS, WHICH WAS IMPLANTED IN 2015. THE NEW TRANSCATHETER VALVE WAS IMPLANTED ON (B)(6) 2025. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21253476 ↗
• InjuryAug 26, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS MODERATE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 20065423 ↗
• InjuryMay 1, 2024Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 6 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS MODERATE-SEVERE AORTIC INSUFFICIENCY (AS), HEART FAILURE WITH HEMODYNAMIC INSTABILITY AND LOW CARDIAC OUTPUT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure; Low Cardiac Output

  MAUDE report 19221353 ↗
• InjuryFeb 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 5 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM AORTIC 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 16303417 ↗
• InjuryJan 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 5 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY 1 DAY LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS (AS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 16189092 ↗
• InjuryApr 13, 2022Perivalvular Leak; Insufficient Device Problem Information; Perivalvular Leak; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 1 MONTH POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC 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: Insufficient Information; Valvular Insufficiency/ Regurgitation

  MAUDE report 14104506 ↗
• InjuryApr 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 9 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 14017631 ↗
• InjuryFeb 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 4 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. SUBSEQUENTLY 1 MONTH LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 13548939 ↗
• InjurySep 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 4 MONTHS POST IMPLANT OF THIS 23MM 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: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Insufficient Information

  MAUDE report 12542398 ↗
• InjuryMar 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 5 YEARS AND 6 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC AORTIC ROOT VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11458218 ↗
• InjuryDec 18, 2020Perivalvular Leak; Insufficient Device Problem Information; Perivalvular Leak; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 4 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC 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: Insufficient Information; Valvular Insufficiency/ Regurgitation

  MAUDE report 11037619 ↗
• InjuryMay 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 6 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10101517 ↗
• InjuryJan 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 9 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9587305 ↗

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-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-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