HANCOCK II ULTRA® T505U225 (UDI 00643169534100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169534100), received between Oct 18, 2017 and Aug 23, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2026Intravalvular regurgitation

  It was reported that 10 years and 6 months post implant of this 25mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was reported as aortic insufficiency. No intervention or adverse patient effects were reported.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50397596 ↗
• InjuryDec 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 6 YEARS 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: Insufficient Information

  MAUDE report 20895229 ↗
• InjuryMar 20, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 7 MONTHS POST IMPLANT OF THIS 25MM AORTIC 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: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 18940443 ↗
• InjuryJun 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 9 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE IMPLANTED IN A THEN 9 YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 17104861 ↗
• InjuryMay 10, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 1 MONTH POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO SEVERE AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 11797260 ↗
• InjuryOct 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 1 MONTH POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPLACED WITH A 26MM TRANSCATHETER AORTIC VALVE DUE TO MODERATE AORTIC STENOSIS AND MODERATE TO SEVERE AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis

  MAUDE report 9171874 ↗
• InjuryMay 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 4 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency

  MAUDE report 8601078 ↗
• InjuryMay 22, 2018Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT TWO DAYS POST IMPLANT OF THIS 25 MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23 MM AORTIC BIOPROSTHETIC VALVE DUE TO SEVERE PARAVALVULAR LEAK (PVL). THE SURGEON STATED THERE WAS NO MALFUNCTION OF THE BIOPROSTHETIC VALVE ITSELF. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7533985 ↗
• InjuryOct 18, 2017Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT WAS BEING CONSIDERED FOR VALVE REPLACEMENT. SUBSEQUENTLY 23 DAYS LATER, THE PATIENT UNDERWENT AN ATTEMPTED REPLACEMENT PROCEDURE WITH A TRANSCATHETER VALVE (VALVE-IN-VALVE). THE ATTEMPTED VALVE-IN-VALVE IMPLANT WAS UNSUCCESSFUL DUE TO PATIENT ANATOMY AND THIS DEVICE REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency; No Information

  MAUDE report 6958809 ↗

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