Open Pivot™ 500DM33 (UDI 00643169334915)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169334915), received between Oct 29, 2018 and Aug 22, 2024 — classified as 1 death, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT SEVERAL WEEKS POST IMPLANT OF THIS 33MM MITRAL MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS, "THE VALVE EXPLODED, LEAVING FRAGMENTS AND FLOATING PIECES OF METAL IN THE HEART". IT WAS ALSO REPORTED THAT THE PATIENT HAD SYMPTOMS OF CONSTANT PAIN, DIFFICULTY WALKING AND OTHER VARIOUS COMPLICATIONS DUE TO THE FLOATING METAL. THE PATIENT WAS HOSPITALIZED AND PLACED IN A NURSING FACILITY WHERE THEY EXPERIENCED SEVERAL FALLS RESULTING IN A BACK FRACTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20027598 ↗
• InjuryDec 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 6 MONTHS POST IMPLANT OF THIS 33MM MITRAL MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL MECHANICAL VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9489588 ↗
• InjuryJun 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS POST IMPLANT OF THIS MITRAL MECHANICAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO SICK SINUS SYNDROME, ATRIAL FIBRILLATION (AFIB), ATRIAL TACHYCARDIA, AND ATRIAL FLUTTER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Atrial Tachycardia

  MAUDE report 8734327 ↗
• InjuryJun 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT'S SPOUSE THAT 9 DAYS POST IMPLANT OF THIS MITRAL MECHANICAL VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8734282 ↗
• DeathOct 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR 4 MONTHS POST IMPLANT OF THIS 33MM MITRAL MECHANICAL VALVE, THE PATIENT PASSED AWAY. THE PATIENTS SPOUSE CALLED TECHNICAL SERVICES INQUIRING ABOUT A RECALL FOR HER HUSBANDS VALVE AS SHE BELIEVED THE DEATH WAS RELATED TO A VALVE MALFUNCTION. THE SPOUSE STATED THAT HER HUSBAND HAD ISSUES 1 WEEK POST IMPLANT, SUCH AS SEVERAL STROKES AND SEIZURES, ALONG WITH A PERICARDIAL EFFUSION AND MYOCARDIAL INFARCTION (MI). THE PATIENTS EJECTION FRACTION WENT FROM 66 DOWN TO 22 DURING THIS TIME AND HAD ISSUES WITH CLOTTING. THE PATIENT SAW SEVERAL PHYSICIANS, NONE OF WHICH COULD PINPOINT ANY ISSUE, HOWEVER THE LAST CARDIOLOGIST THE PATIENT SAW, STATED THAT THEY THOUGHT THE VALVE WAS "FAILING". IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE VALVE WAS BURIED WITH THE PATIENT.

  Patient problems: Death; Myocardial Infarction; Pericardial Effusion

  MAUDE report 8015329 ↗

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