HANCOCK® II T505U223Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00643169000438), received between Feb 21, 2017 and Sep 9, 2026 — classified as 4 deaths, 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Device Stenosis

  Additional Information received reported that on (b)(6) 2026, the patient successfully had a 23mm aortic transcatheter valve-in-valve replacement. No additional adverse patient effects were reported.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50687756 ↗
• InjuryMar 30, 2026Device Stenosis

  IT WAS REPORTED THAT 11 YEARS AND 2 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS VALVE STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24728190 ↗
• DeathAug 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE VALVE COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 22748824 ↗
• DeathJun 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 8 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE VALVE COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 22289147 ↗
• InjuryMay 20, 2025Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 9 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO CARDIOGENIC SHOCK CAUSED BY SEVERE AORTIC INSUFFICIENCY. SUBSEQUENTLY, 1 DAY LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Shock

  MAUDE report 22053820 ↗
• InjuryDec 10, 2024Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE REASON FOR INTERVENTION WAS AORTIC STENOSIS AND MILD AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20894599 ↗
• InjuryApr 1, 2024Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 10 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 REPORTED AS HIGH GRADIENTS. IT WAS STATED THAT THE PATIENT WAS ALSO EXPERIENCING SHORTNESS OF BREATH (SOB). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY 21 DAYS LATER, THE PATIENT HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea

  MAUDE report 19012171 ↗
• InjuryJan 30, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR REPLACEMENT WAS MODERATE AORTIC REGURGITATION (AR). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 18607383 ↗
• InjuryJan 8, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR INTERVENTION WAS REPORTED MODERATE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18465896 ↗
• InjuryDec 28, 2023Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 1 MONTH 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 9 DAYS LATER, THE PATIENT HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 18409611 ↗
• InjuryApr 6, 2023Gradient Increase; Perivalvular Leak; Material Separation; Insufficient Device Problem Information; Gradient Increase; Perivalvular Leak; Material Separation; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS MODERATE TO SEVERE AORTIC PARAVALVULAR REGURGITATION, SEVERE AORTIC STENOSIS AND A AORTIC ROOT PSEUDOANEURYSM. IT WAS STATED THAT THE VALVE WAS OBSERVED TO BE PARTIALLY DEHISCED INDICATING THE OPENING OF A PSEUDOANEURYSM. IT WAS NOTED THAT THERE WAS A BIG PSEUDOANEURYSM AT THE POSTERIOR ASPECT OF THE LEFT CORONARY SINUS AND ANOTHER PSEUDOANEURYSM IN THE NONCORONARY SINUS LEVEL. THE VALVE AND PSEUDOANEURYSM WERE OBSERVED TO BE CALCIFIED. IT WAS REPORTED THAT THERE WERE TWO PARAVALVULAR OPENINGS, ONE GOING TO THE LEFT CORONARY SINUS AND ANOTHER TO THE NONCORONARY SINUS. IT WAS ALSO STATED THAT PEAK AND MEAN TRANSVALVULAR GRADIENTS OF 85MMHG AND 44MMHG. IT WAS ALSO REPORTED THAT THE VISUAL LEFT VENTRICULAR EJECTION FRACTION (LVEF) WAS 40-45%, THE MAX LEFT VENTRICULAR OUTFLOW TRACT (LVOT) WAS 1.16 M/S, THE RIGHT VENTRICULAR SYSTOLIC PRESSURE WAS MILDLY INCREASED, THE LEFT ATRIUM WAS MODERATELY DILATED AND THE AORTIC VALVE AREA (AVA) WAS 1.1 CM2. THE PATIENT EXPERIENCED SYMPTOMS OF SHORTNESS OF BREATH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 16690826 ↗
• InjuryOct 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 5 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 14 DAYS LATER, THE PATIENT HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 15607663 ↗
• InjuryFeb 28, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 6 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. SUBSEQUENTLY 10 DAYS LATER, THE PATIENT SUCCESSFULLY HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER VALVE DUE TO AORTIC STENOSIS AND AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 13622716 ↗
• InjuryOct 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 8 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A NON MEDTRONIC 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 12563117 ↗
• DeathMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT TWO DAYS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE THE PATIENT WAS HYPOXIC AND REQUIRED BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) THERAPY AND ULTIMATE RE-INTUBATION. RESPIRATORY CULTURES WERE POSITIVE FOR SERRATIA MARCESCENS AND KLEBSIELLA PNEUMONIAE, AND ANTIBIOTIC TREATMENT WAS INITIATED. THE PATIENT DEVELOPED PERSISTENT FEVER WITH LEUKOCYTOSIS AND LACTIC ACIDOSIS. ANTIBIOTIC THERAPY CONTINUED FOR PNEUMONIA WHICH PROGRESSED TO HEMODYNAMIC INSTABILITY REQUIRING PRESSOR THERAPY. DUE TO PERSISTENT HYPOXEMIA, ULTRASOUND WAS PERFORMED AND WAS POSITIVE FOR DEEP VEIN THROMBOSIS, AND THE PATIENT WAS GIVEN ANTICOAGULATION TREATMENT. ELEVEN DAYS POST IMPLANT, TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED A WELL SEATED VALVE WITH TRACE AORTIC INSUFFICIENCY AND AORTIC VALVE ENDOCARDITIS. EIGHTEEN DAYS POST IMPLANT THE 23MM VALVE, A RE-DO AORTIC VALVE REPLACEMENT (AVR) WAS PERFORMED. PRIOR TO THE SURGERY THE SURGEON CITIED AN 80% CHANCE OF MORTALITY DUE TO THE PATIENT'S OVERALL ILL CONDITION. THE 23MM VALVE WAS EXAMINED INTRAOPERATIVELY, THROMBI AND VEGETATIONS WERE PRESENT ON THE NON-CORONARY LEAFLET AND PARAVALVULAR LEAK (PVL) WAS PRESENT AT THE RIG

  Patient problems: Endocarditis; Respiratory Failure; Thrombosis/Thrombus; Unspecified Infection; Valvular Insufficiency/ Regurgitation

  MAUDE report 11570710 ↗
• InjuryFeb 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 6 YEARS AND 9 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC AORTIC 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 9764050 ↗
• DeathJun 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 57 DAYS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS INFECTIOUS ENDOCARDITIS. THE SOURCE OF THE INFECTION WAS NOT REPORTED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Endocarditis

  MAUDE report 8745251 ↗
• InjuryDec 27, 2018Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT SIX YEARS AND THREE MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO INCREASED GRADIENT MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8199982 ↗
• InjuryOct 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 3 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE DEVICE WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER VALVE DUE TO STENOSIS AND REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Regurgitation; Aortic Valve Stenosis

  MAUDE report 6911869 ↗
• InjuryFeb 21, 2017Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS 2 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC AORTIC VALVE, THIS DEVICE WAS REPLACED, VALV E-IN-VALVE WITH A TRANSCATHETER BIOPROSTHETIC VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis; Dyspnea; No Information

  MAUDE report 6347670 ↗

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