Open Pivot™ 500DM25 (UDI 00643169335042)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169335042), received between Jun 26, 2017 and Mar 4, 2021 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (P990046); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 25MM MECHANICAL MITRAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT. THE REASON FOR THE PERMANENT PACEMAKER IMPLANT WAS REPORTED AS COMPLETE HEART BLOCK WITH SICK SINUS SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block; Non specific EKG/ECG Changes

  MAUDE report 11416735 ↗
• InjuryAug 19, 2019Off-Label Use; Insufficient Device Problem Information; Off-Label Use; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 25MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE PROCEDURE FOR UNKNOWN REASONS. IT WAS REPLACED WITH A 25MM MITRAL MECHANICAL VALVE. THREE DAYS LATER THE PATIENT ALSO HAD A TRICUSPID BIOPROSTHETIC VALVE IMPLANTED AND LATER THAT DAY PASSED AWAY. NO CAUSE OF DEATH HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Information

  MAUDE report 8906136 ↗
• InjuryJan 6, 2019Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 25MM MITRAL MECHANICAL VALVE WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE DEVICE WAS REPLACED WITH A 24MM MECHANICAL VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8220646 ↗
• DeathAug 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 29 MM MECHANICAL VALVE IN A PATIENT WITH RHEUMATIC VALVE DISEASE, DUE TO ANNULAR RUPTURE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 25 MM VALVE OF THE SAME MODEL. SUBSEQUENTLY THE PATIENT DIED. IT WAS REPORTED THAT THE DEATH WAS NOT RELATED TO THE VALVE OR ITS FUNCTION NOR WAS THERE ANY ALLEGATION THAT THE VALVE CONTRIBUTED TO THE PATIENT'S DEATH.

  Patient problems: Death

  MAUDE report 6793984 ↗
• InjuryJun 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOUR MONTHS FOLLOWING THE IMPLANT OF THIS MECHANICAL VALVE IN THE MITRAL POSITION, THIS DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC MITRAL VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6668700 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990046. One submission often covers many models, so check the product and lot details in each record.

• Z-1533-2020 · Feb 11, 2020 · Terminated
  Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
• Z-0634-04 · Feb 18, 2004 · Terminated
  ATS Open Pivot Mechanical Heart Valve