HANCOCK® II T505C223 (UDI 00643169594302)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169594302), received between Nov 13, 2017 and Sep 15, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Insufficient Device Problem Information

  Medtronic received information that 7 years and 7 months post implant of this 23mm aortic bioprosthetic valve, it was explanted and replaced with a 25mm aortic bioprosthetic valve of a different model. The reason for the replacement was not reported. No additional adverse patient effects were reported.

  Patient problems: Insufficient Information

  MAUDE report 50767165 ↗
• InjuryAug 23, 2026Intravalvular regurgitation

  It was reported that 8 years and 10 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 aortic insufficiency. No intervention or adverse patient effects were reported.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50397593 ↗
• InjuryJan 21, 2026Fluid/Blood Leak; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 9 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ENDOCARDITIS INFECTION. THE ORGANISM CULTURED WAS E. FAECALIS. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. SUBSEQUENTLY, 4 DAYS LATER, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT (ED) WITH MONOCULAR LEFT EYE VISION, A NEW OCCLUSION OF LEFT INTERNAL CAROTID ARTERY (ICA), AND EVIDENCE OF ATRIAL FLUTTER. MEDICATION WAS ADMINISTERED. THEN, 2 MONTHS LATER, THE PATIENT AS ADMITTED TO THE ED FOR CHEST PAIN. A COMPUTERIZED TOMOGRAPHY (CT) SCAN DISCOVERED PROLAPSE OR FLAIL OF THE RIGHT CORONARY CUSP OF THE AORTIC VALVE, WHICH ALSO LED TO SEVERE AORTIC REGURGITATION AND AORTIC STENOSIS. SUBSEQUENTLY, ON DECEMBER 26, 2025, THE PATIENT SUCCESSFULLY HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Atrial Flutter; Chest Pain; Endocarditis; Obstruction/Occlusion

  MAUDE report 24132321 ↗
• InjuryJun 25, 2025Calcified; Gradient Increase; Thickening of Material; Calcified; Gradient Increase; Thickening of Material

  MEDTRONIC RECEIVED INFORMATION THAT AFTER AN UNKNOWN DURATION 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, CALCIFICATION AND LEAFLET THICKENING. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 3 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 22328778 ↗
• MalfunctionSep 17, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 8 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 AORTIC STENOSIS. IT WAS STATED THAT CALCIUM WAS SEEN BELOW THE LEFT CORONARY CUSP (LCC) AND RIGHT CORONARY CUSP (RCC). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 20241150 ↗
• InjuryNov 9, 2023Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION 4 YEARS AND 12 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 SEVERE TRANSVALVULAR AORTIC INSUFFICIENCY (AI). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18101914 ↗
• InjuryNov 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 18 DAYS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIOVENTRICULAR (AV BLOCK). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 18049318 ↗
• InjuryFeb 28, 2023Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 3 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 NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 17 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS INCREASED GRADIENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16451988 ↗
• InjuryJun 28, 2021Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 3 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE VALVE WAS REPLACED DUE TO INCREASED GRADIENTS AND AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENTEFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 12079863 ↗
• InjurySep 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 7 MONTHS POST IMPLANT OF THIS 23MM BIOPROSTHETIC AORTIC VALVE, IT WAS REPLACED VALVE-IN-VALVE WITH A 23MM TRANSCATHETER VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS AORTIC INSUFFICIENCY. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING PROGRESSIVE HEART FAILURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency; Heart Failure

  MAUDE report 8976082 ↗
• InjuryApr 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS BIOPROSTHETIC VALVE, COMPLETE HEART BLOCK WAS REPORTED AND REQUIRED DUAL CHAMBER PACING. RHYTHM DID NOT RETURN TO NORMAL SINUS RHYTHM AND A PERMANENT PACEMAKER WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 7454920 ↗
• InjuryNov 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL VALVE OF THE SAME SIZE. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7025146 ↗

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-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-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-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