Open Pivot™ 500DM29 (UDI 00643169335066)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169335066), received between Jun 12, 2017 and Apr 1, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 YEARS AND 11 MONTHS POST IMPLANT OF THIS 18MM AORTIC MECHANICAL VALVE AND 29MM MITRAL MECHANICAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SINUS BRADYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 24752848 ↗
• InjuryMay 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 6 MONTHS POST IMPLANT OF THIS 29MM MITRAL MECHANICAL VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR IMPLANT WAS REPORTED AS PRIMARY PREVENTION AND CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22010845 ↗
• InjuryAug 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 8 MONTHS POST IMPLANT OF THIS 29MM MITRAL MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15285672 ↗
• InjuryMar 3, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT THIS 29MM MITRAL MECHANICAL VALVE WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. AFTER PARTIALLY SUTURING THE 29MM INTO PLACE, THE SURGEON REPORTED THAT IT WASN'T A GOOD FIT, SO IT WAS REMOVED AND A 27MM MITRAL MECHANICAL VALVE WAS SUCCESSFULLY IMPLANTED IN ITS PLACE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9779649 ↗
• InjuryDec 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 MONTHS 9 DAYS POST IMPLANT OF THIS 29MM MITRAL MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8155036 ↗
• InjuryOct 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE HOSPITAL STAY, POST IMPLANT OF THIS MITRAL MECHANICAL VALVE, THE PATIENT DEVELOPED A JUNCTIONAL RHYTHM WHICH WAS TREATED WITH THE IMPLANT OF A PERMANENT PACEMAKER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia

  MAUDE report 7951852 ↗
• InjuryDec 6, 2017Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT 9 MONTHS POST IMPLANT OF THIS 29 MM MECHANICAL VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 27 MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS PARAVALVULAR LEAK (PVL) DUE TO A SUTURE TEARING THROUGH THE TISSUE. THE VALVE WAS REPORTED TO BE FUNCTIONING NORMALLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Skin Tears

  MAUDE report 7088004 ↗
• InjurySep 27, 2017Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT EIGHT DAYS POST IMPLANT OF THIS MITRAL MECHANICAL VALVE, THE ELECTROCARDIOGRAM (ECG) SHOWED COMPLETE HEART BLOCK (CHB) AND SUBSEQUENTLY A PERMANENT PACEMAKER WAS IMPLANTED. APPROXIMATELY THREE MONTHS POST IMPLANT THE PATIENT WAS HOSPITALIZED FOR ANEMIA WITH INTERMITTENT HEMOLYSIS. BLOOD TRANSFUSIONS WERE PRESCRIBED. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED MILD PARAVALVULAR LEAK. TWO YEARS TWENTY-SEVEN DAYS POST IMPLANT, THE VALVE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DONE POST IMPLANT SHOWED NO PARAVALVULAR LEAK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block; Hemolytic Anemia

  MAUDE report 6899072 ↗
• InjurySep 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 29MM MITRAL MECHANICAL VALVE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY FOR UNKNOWN REASONS. THE DEVICE WAS REPLACED WITH A 29MM MITRAL MECHANICAL VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6856975 ↗
• InjuryAug 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: Rupture

  MAUDE report 6793978 ↗
• InjuryJun 12, 2017Incomplete Coaptation; Incomplete Coaptation

  MEDTRONIC RECEIVED INFORMATION THAT ONE YEAR AND TWO MONTHS POST IMPLANT OF THIS MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED DUE TO THROMBOSIS OF ONE OF THE LEAFLETS IN THE CLOSED POSITION. IT WAS REPORTED THAT THE PATIENT DISCONTINUED ANTICOAGULANT THERAPY FOR APPROXIMATELY ONE MONTH, WHICH WAS IDENTIFIED AS THE REASON FOR THE CLOTTING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Thrombosis

  MAUDE report 6635996 ↗

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