HANCOCK® II T505C227 (UDI 00643169534063)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169534063), received between Nov 6, 2025 and Jul 29, 2026 — classified as 3 injuries.

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

• InjuryJul 29, 2026Device Stenosis

  It was reported that 10 years and 9 months post implant of this 27mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was reported as stenosis. It was reported that an intervention is required. Subsequently 3 days later on (b)(6) 2026 the patient successfully had a 26mm aortic transcatheter valve-in-valve replacement. No additional adverse patient effects were reported.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50068756 ↗
• InjuryJan 21, 2026Gradient Increase; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 8 MONTHS POST IMPLANT OF THIS 27MM HANCOCK II AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS MODERATE AORTIC REGURGITATION (AR) AND LOW EJECTION FRACTION (EF). A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED MODERATE AORTIC VALVE REGURGITATION, LIKELY DUE TO A TORN AND FLAIL ANATOMIC RIGHT CORONARY CUSP OF THE BIOPROSTHETIC AORTIC VALVE AND GLOBAL MILD LEFT VENTRICULAR SYSTOLIC DYSFUNCTION WAS OBSERVED, WITH EJECTION FRACTION AT 45% BY VISUAL ESTIMATE. A SUBSEQUENT ECHOCARDIOGRAM SHOWED LOW EJECTION FRACTION (EF) (36%), WITH A MEAN GRADIENT OF 21MMHG AND PULMONARY PRESSURE WAS ELEVATED AT 47 MMHG. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24132270 ↗
• InjuryNov 6, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON (B)(6) 2025, THE PATIENT SUCCESSFULLY HAD A 26MM TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 23484274 ↗

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