HANCOCK® II T505C227 (UDI 00613994760562)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994760562), received between Jun 28, 2018 and Nov 18, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REASON FOR INTERVENTION WAS MODERATE AORTIC REGURGITATION (AR) AND SEVERE AORTIC STENOSIS (AS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23582051 ↗
• InjuryJan 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 1 MONTH POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY (AI). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16120678 ↗
• InjuryJun 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 4 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO SEVERE STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 7648476 ↗

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