HANCOCK® II T505C227 (UDI 00643169594326)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169594326), received between Oct 16, 2017 and Aug 22, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2025Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Intravalvular regurgitation; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 6 MONTHS POST IMPLANT OF THIS 27MM HANCOCK II VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM MOSAIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS AORTIC ROOT ABSCESS AND SIGNIFICANT AORTIC INSUFFICIENCY (AI) DUE TO ACUTE BACTERIAL ENDOCARDITIS. ANTIBIOTICS WERE ADMINISTERED. IT WAS FURTHER REPORTED THAT VEGETATION WAS PRESENT ON THE VALVE. THE ORGANISM CULTURED WAS STREP. ANGINOSIS. THE PATIENT HAD A COLONOSCOPY PROCEDURE 1 MONTH PRIOR TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Endocarditis

  MAUDE report 22872643 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE IMPLANTED IN THE PULMONARY POSITION, 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 17998899 ↗
• InjuryNov 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 4 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE IMPLANTED IN THE PULMONARY POSITION, 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; Tricuspid Valve Insufficiency/ Regurgitation; Tricuspid Valve Stenosis

  MAUDE report 12799169 ↗
• InjuryOct 16, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS BIOPROSTHETIC VALVE, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED AN ANNULAR FISTULA TO THE RIGHT ATRIUM. BYPASS WAS RE-INITIATED AND THE VALVE WAS EXPLANTED AND REPLACED. A PERICARDIAL PATCH TO THE AORTIC ANNULUS AND THE RIGHT ATRIAL SEPTAL WALL WAS PLACED. THE ELECTROCARDIOGRAM (ECG) SHOWED COMPLETE HEART BLOCK (CHB) RESOLVED WITH TEMPORARY PACING. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fistula; Regurgitation, Valvular

  MAUDE report 6951963 ↗

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