HANCOCK® II T510C27 (UDI 00643169594401)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169594401), received between Mar 27, 2018 and Jan 5, 2026 — classified as 1 death, 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 MONTH POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SYNCOPE AND ATRIAL ARRYTHMIAS (ATRIAL TACHYCARDIA (AT), ATRIAL FIBRILLATION (AF) AND ATRIAL FLUTTER (A-FL)). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Syncope/Fainting; Tachycardia

  MAUDE report 23955523 ↗
• InjurySep 15, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS POST IMPLANT OF THIS 27MM HANCOCK II VALVE, IT WAS EXPLANTED AND REPLACED WITH A DEVICE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23049606 ↗
• InjuryFeb 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. IT WAS ALSO REPORTED THAT THE VALVE WAS "USED/NOT IMPLANTED". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18640918 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 17998976 ↗
• InjuryFeb 23, 2023Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT WHEN THE PHYSICIAN WENT TO SECURE THE VALVE SUTURES, ONE OF THE BLACK RETENTION SUTURES BROKE. THE PHYSICIAN DECIDED THE BROKEN SUTURE WAS NOT FIXABLE AND THE VALVE WAS NOT ABLE TO BE IMPLANTED. IT WAS REPORTED THAT THE 27MM MITRAL BIOPROSTHETIC VALVE WAS EXPLANTED AND REPLACED WITH A VALVE OF THE SAME SIZE AND MODEL. IT WAS NOTED THAT ADDITIONAL SUTURE HOLES IN THE MITRAL ANNULUS WERE REQUIRED AS A RESULT AS WELL AS LONGER CLAMP AND ANESTHESIA TIME. IT WAS REPORTED THAT THE VALVE WAS "FULLY SUTURED BUT WAS NOT PARACHUTED DOWN AND THE SUTURES WERE NOT TIED INTO THE SEWING CUFF". IT WAS STATED THAT THE VALVE WAS TESTED PRIOR TO REMOVAL AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16428697 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 25 DAYS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIAL ARRHYTHMIAS (ATRIAL FIBRILLATION (AF), ATRIAL TACHYCARDIA (AT) AND ATRIAL FLUTTER (AFL) ). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Non specific EKG/ECG Changes

  MAUDE report 16103675 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT ONE WEEK POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 15789262 ↗
• InjuryJan 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT OF THIS MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO UNSPECIFIED ATRIO-VENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 11144233 ↗
• DeathOct 21, 2019Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 MONTHS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 25MM MITRAL BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiogenic Shock; Death; No Information; Thrombus

  MAUDE report 9214091 ↗
• InjuryApr 17, 2019Adverse 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 EIGHT MONTHS POST IMPLANT OF THIS 27 MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31 MM BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; No Information

  MAUDE report 8524258 ↗
• InjuryJul 26, 2018Leak/Splash

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY AFTER IMPLANTING THIS BIOPROSTHETIC VALVE, THE SURGEON NOTED A LEAK ALONG THE ANNULUS OF THE VALVE ON THE INSIDE OF THE RIGHT TRIGONE MARKER. THE VALVE WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Information

  MAUDE report 7722595 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS MITRAL BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A VALVE OF THE SAME MODEL DUE TO USER ERROR. THE PHYSICIAN REPORTED THERE WAS NO ISSUE WITH THE VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7615681 ↗
• InjuryJun 11, 2018Insufficient 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 AN UNKNOWN DEVICE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7586789 ↗
• InjuryMar 27, 2018Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT THIS 27 MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE DUE TO CALCIFICATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 7373966 ↗

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-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-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-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