HANCOCK® II T505C227 (UDI 00643169000377)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169000377), received between Sep 28, 2017 and Jun 15, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 2 MONTHS POST IMPLANT OF THIS 27 MM HANCOCK II 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.

  Patient problems: Insufficient Information

  MAUDE report 25500059 ↗
• InjurySep 10, 2025Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 5 MONTHS POST IMPLANT OF THIS HANCOCK II AORTIC 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.

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

  MAUDE report 23014807 ↗
• InjuryApr 3, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 7 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21762657 ↗
• InjuryJan 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS HANCOCK II AORTIC 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 21241414 ↗
• InjuryDec 13, 2024Gradient Increase; Incomplete Coaptation; Insufficient Device Problem Information; Thickening of Material; Device Stenosis; Gradient Increase; Incomplete Coaptation; Insufficient Device Problem Information; Thickening of Material; Device Stenosis

  IT WAS REPORTED THAT A NEW TISSUE VALVE WAS IMPLANTED IN THE AORTIC POSITION. THE PATIENT HAD AN EXISTING TISSUE VALVE IMPLANTED IN THE SAME POSITION. THE OLD VALVE WAS EXPLANTED.

  Patient problems: Aortic Valve Stenosis; Dyspnea; Fatigue; Foreign Body Reaction; Insufficient Information

  MAUDE report 20923014 ↗
• InjuryMar 7, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION 10 YEARS AND 11 MONTHS POST IMPLANT OF THIS 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 7 DAYS LATER, THE PATIENT HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS SEVERE AORTIC REGURGITATION (AR). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18857716 ↗
• InjuryOct 31, 2023Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REASON FOR INTERVENTION WAS SEVERE AORTIC INSUFFICIENCY (AI). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18040588 ↗
• InjuryOct 20, 2023Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 11 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 17972776 ↗
• InjuryJul 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS POST IMPLANT OF THIS 27MM 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: Insufficient Information

  MAUDE report 12252541 ↗
• InjuryOct 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 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: Aortic Regurgitation; Aortic Valve Stenosis; No Information

  MAUDE report 10613816 ↗
• InjuryAug 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 8 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER AORTIC VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 10475159 ↗
• InjuryDec 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS 4 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE DEVICE WAS REPLACED V ALVE-IN-VALVE WITH A 29MM TRANSCATHETER AORTIC VALVE FOR AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 9495312 ↗
• InjuryOct 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS 7 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT PRESENTED WITH AORTIC REGURGITATION. THE PATIENT UNDERWENT AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Regurgitation

  MAUDE report 6984593 ↗
• InjurySep 28, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS 10 MONTHS, POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE DEVICE WAS REPLACED FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Anemia; Blood Loss; Death; Hemostasis; Low Blood Pressure/ Hypotension; No Information; Unspecified Infection

  MAUDE report 6900857 ↗

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-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-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-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