HANCOCK II ULTRA® T505U225 (UDI 00643169594593)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169594593), received between Nov 2, 2017 and Sep 4, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY AS THE IMPLANT OF THIS HANCOCK II VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22962096 ↗
• InjuryAug 18, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 3 MONTHS POST IMPLANT OF THIS HANCOCK II VALVE IN THE PULMONARY POSITION, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 22825652 ↗
• InjuryJul 11, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 8 MONTHS POST IMPLANT OF THIS HANCOCK II AORTIC VALVE, THE PATIENT WAS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 2 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22480011 ↗
• InjuryJul 9, 2025Insufficient Device Problem Information; Material Split, Cut or Torn; Intravalvular regurgitation; Insufficient Device Problem Information; Material Split, Cut or Torn; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE 25MM HANCOCK II VALVE WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY. IT WAS STATED THAT THERE WERE "SOME BURNED OUT DEBRIS ON THE AORTIC VALVE WITH ONE TORN LEAFLET". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cusp Tear; Insufficient Information

  MAUDE report 22455710 ↗
• InjuryJul 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 2 YEARS AND 1 MONTH POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12199825 ↗
• InjuryMay 19, 2021Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  \MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 5 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. PRIOR TO REPLACEMENT, THE PATIENT CALLED MEDTRONIC TO REPORT THAT THEIR BIOPROSTHETIC VALVE WAS "NOT WORKING PROPERLY". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 11849625 ↗
• InjuryNov 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 25 MM BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 23 MM BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. THE BLOOD PRESSURE WAS ELEVATED AND ELECTROCARDIOGRAM (ECG) SHOWED ELEVATED ST SEGMENTS. NO FAILURE MECHANISM OF THE 25 MM BIOPROSTHETIC VALVE WAS REPORTED. THE SURGEON REPORTED THE 25 MM VALVE OCCLUDED THE RIGHT CORONARY OSTIA AND THE SAME EFFECTIVE ORIFICE AREA (EOA) WAS ACCOMPLISHED WITH THE 23 MM VALVE. FOLLOWING THE IMPLANT OF THE 23 MM BIOPROSTHETIC VALVE, NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: High Blood Pressure/ Hypertension; Non specific EKG/ECG Changes; Occlusion

  MAUDE report 6997301 ↗

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