Open Pivot™ 505DA24Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169334991), received between Dec 30, 2016 and Nov 7, 2025 — classified as 1 death, 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 2 DAYS POST IMPLANT OF THIS 24MM AORTIC MECHANICAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 23494813 ↗
• InjuryNov 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 9 YEARS AND 11 MONTHS POST IMPLANT OF THIS 24MM AORTIC MECHANICAL HEART VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM AORTIC BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23474473 ↗
• InjuryMay 13, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 24MM AORTIC MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 22MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS "SIZING ISSUES".  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14397910 ↗
• InjuryFeb 9, 2021Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 3 YEARS POST IMPLANT OF THIS 24MM AORTIC MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A MECHANICAL VALVE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Valvular Insufficiency/ Regurgitation

  MAUDE report 11301326 ↗
• InjuryNov 30, 2020Inadequacy 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 AN UNKNOWN DURATION POST IMPLANT OF THIS AORTIC MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 24MM AORTIC MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 10918932 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF THIS 24MM MECHANICAL AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT. THE REASON FOR THE PACEMAKER IMPLANT WAS REPORTED AS INCOMPLETE ATRIO-VENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 10636727 ↗
• InjuryAug 2, 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 DURING THE IMPLANT OF THIS 24MM MECHANICAL VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH 22MM MECHANICAL VALVE. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8855444 ↗
• InjuryOct 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 24MM AORTIC MECHANICAL VALVE WAS NOT USED. INSTEAD, AN AORTIC GRAFT WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7926568 ↗
• DeathDec 30, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE OF THIS MECHANICAL VALVE. THE CAUSE OF DEATH WAS REPORTED TO POSSIBLY BE BECAUSE THE PATIENT NEVER RECEIVED RETROGRADE CARDIOPLEGIA; THE PATIENT ONLY RECEIVED ANTEGRADE CARDIOPLEGIA. THEREFORE, THE PATIENT HAD A "STONE HEART" WHEN TRYING TO GET HIM OFF PUMP. WITH A 20% EJECTION FRACTION (EF), ANTEGRADE PERFUSION ALONE PROVED TO BE INSUFFICIENT, AND THE PATIENT'S HEART DID NOT REGAIN BEATING AFTER COMING OFF OF CARDIOPULMONARY BYPASS. THERE WERE NO ALLEGATIONS AGAINST THE VALVE OR ITS FUNCTION. IT IS NOT KNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Death

  MAUDE report 6215433 ↗

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