Open Pivot™ 500DM31 (UDI 00643169335073)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169335073), received between Aug 10, 2022 and Mar 5, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY POST IMPLANT OF THIS 31MM MITRAL MECHANICAL VALVE, IT WAS REPORTED BY THE PATIENT THAT THEY HAD ACQUIRED SEPSIS AND WERE HOSPITALIZED FOR 15 DAYS. IT WAS ALSO REPORTED BY THE PATIENT THAT MEDICATION WAS GIVEN FOR THE SEPSIS. THEY REPORTED SYMPTOMS OF FATIGUE, LACK OF ENERGY AND WINDED WHEN WALKING. THE PATIENT ALSO REPORTED THAT THEY RECEIVED AN ABLATION 3 YEARS AND 5 MONTHS POST IMPLANT. IT IS UNKNOWN WHY THE ABLATION WAS PERFORMED. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Sepsis

  MAUDE report 18842258 ↗
• InjuryAug 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 10 MONTHS POST IMPLANT OF THIS 31MM MITRAL MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15202695 ↗

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