HANCOCK® II T510C27 (UDI 00643169594456)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169594456), received between Jan 23, 2019 and Apr 22, 2020 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathApr 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS PATIENT UNDERWENT MITRAL VALVE REPLACEMENT DUE TO SEVERE MITRAL STENOSIS SECONDARY TO CALCIFICATION, AS WELL AS MODERATE MITRAL REGURGITATION. IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIUM WAS "VERY THIN" AND DILATED IN ALL CAVITIES. IT WAS ALSO REPORTED THAT THE TISSUE ON THE ATRIOVENTRICULAR GROOVE WAS POOR, WHICH THE SURGEON REPORTED WAS A SIGN OF CHRONIC INFLAMMATION. THE VALVE WAS SUCCESSFULLY IMPLANTED WITH NO REGURGITATION OR BLEEDING NOTED. FOLLOWING MITRAL VALVE REPLACEMENT, PRIOR TO DISCONTINUING CARDIOPULMONARY BYPASS (CPB), THE RIGHT VENTRICLE BECAME DILATED AND THE PULMONARY ARTERY WAS "TENSE". A PULMONARY SUMP WAS IMPLANTED WHICH WAS REPORTED TO DECOMPRESS THE HEART. TEMPORARY PACING WIRES WERE INSERTED IN THE LEFT APPENDAGE. WHILE ATTEMPTING TO REMOVE THIS PATIENT FROM CARDIOPULMONARY BYPASS (CPB), BLEEDING WAS NOTED BEHIND THE HEART. IT WAS REPORTED THAT THE BLEEDING WAS DETERMINED TO BE A RESULT OF SPONTANEOUS RUPTURE OF THE CRUX OF THE HEART SECONDARY TO DISTENTION OF THE HEART ONCE THE HEART HAD STARTED BEATING AGAIN. THE RUPTURE WAS ATTEMPTED TO BE REPAIRED FOR SEVERAL HOURS. ULTIMATELY THE PATIENT EXPIRED IN THE OPERAT

  Patient problems: Death; Exsanguination; Rupture; Tissue Damage

  MAUDE report 9985440 ↗
• InjuryJan 23, 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 IMMEDIATELY POST IMPLANT OF THIS MITRAL BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A VALVE OF THE SAME SIZE AND MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8270840 ↗

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-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-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