HANCOCK II ULTRA® T505U223 (UDI 00613994772725)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994772725), received between Dec 26, 2018 and Apr 3, 2025 — classified as 8 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2025Device Stenosis; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT 1 MONTH LATER, THE PATIENT SUCCESSFULLY HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRA NSCATHETER VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21762542 ↗
• InjuryMar 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 6 YEARS 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: Insufficient Information

  MAUDE report 21713422 ↗
• InjuryMay 7, 2024Gradient Increase; Insufficient Device Problem Information; Device Stenosis; Gradient Increase; Insufficient Device Problem Information; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 9 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 Valve Stenosis; Insufficient Information

  MAUDE report 19257814 ↗
• InjuryNov 11, 2020Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 6 MONTHS POST IMPLANT OF THIS 23MM BIOPROSTHETIC 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: Aortic Valve Stenosis; No Information

  MAUDE report 10823029 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT FIVE DAYS POST IMPLANT OF THIS BIOPROSTHETIC AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO INCOMPLETE HEART BLOCK AND SYNCOPE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes; Syncope

  MAUDE report 9362669 ↗
• InjuryNov 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 9 YEARS POST IMPLANT OF THIS 23MM BIOPROSTHETIC AORTIC VALVE, IT WAS REPLACED VALVE-IN-VALVE WITH A 23MM TRANSCATHETER VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 9335354 ↗
• InjuryApr 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 8 YEARS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS SUCCESSFULLY REPLACED VALVE-IN-VALVE DUE TO SEVERE AORTIC STENOSIS AND INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis

  MAUDE report 8561797 ↗
• InjuryDec 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT SEVEN YEARS AND SIX MONTHS POST IMPLANT OF THIS BIOPROSTHETIC AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS. NO INTERVENTIONS HAVE OCCURRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. APPROXIMATELY SEVEN YEARS AND FIVE MONTHS POST IMPLANT OF THIS 23MM BIOPROSTHETIC AORTIC VALVE, THE PATIENT DEVELOPED INCREASING SHORTNESS OF BREATH WITH EXERTION. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED DEGENERATIVE STENOSIS AND MILD INSUFFICIENCY. THE MEAN GRADIENT WAS 45MMHG, WITH AN ESTIMATED VALVE AREA OF 1CM2. ULTIMATELY, SEVEN YEARS AND SEVEN MONTHS POST IMPLANT, A 26MM TRANSCATHETER AORTIC VALVE (TAV) WAS ATTEMPTED TO BE IMPLANTED VALVE-IN-VALVE. DURING THE IMPLANT PROCEDURE, THE TAV COULD NOT BE POSITIONED APPROPRIATELY WITHIN THE PREVIOUS BIOPROSTHETIC VALVE, AND THE TAV REMAINED SUSPENDED IN THE ASCENDING AORTA DURING AND AFTER THE PROCEDURE. THE FOLLOWING DAY THE PATIENT UNDERWENT SURGICAL RESECTION OF THE ATTEMPTED TAV AND PREVIOUS BIOPROSTHETIC VALVE. A 25MM BIOPROSTHETIC VALVE OF THE SAME MODEL AS THE "ORGINAL" VALVE WAS SUCCESSFULLY IMPLANTED. INTRAOPERATIVELY THERE WAS "EVIDENCE OF CHR

  Patient problems: Aortic Regurgitation; Aortic Valve Stenosis; Calcium Deposits/Calcification; Regurgitation; Stenosis

  MAUDE report 8195744 ↗

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