HANCOCK II ULTRA® T505U221 (UDI 00643169594524)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169594524), received between Oct 20, 2021 and Oct 20, 2021 — classified as 1 death.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 21 MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT HAD LOW EJECTION FRACTION AND WAS "HAVING A HARD TIME COMING OFF PUMP". IT WAS REPORTED THAT THE PATIENT DIED THE SAME DAY AS THE SURGERY AND THE AORTIC BIOPROSTHETIC VALVE WAS NOT DEFECTIVE OR THE CAUSE OF DEATH. THE CAUSE OF DEATH WAS NOT REPORTED AND THERE WAS NO INFORMATION REPORTED TO SUGGEST THAT MEDTRONIC DEVICES CAUSED OR CONTRIBUTED TO THE DEATH. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

  Patient problems: Low Cardiac Output

  MAUDE report 12669065 ↗

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