Open Pivot™ 500DM27 (UDI 00613994960252)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994960252), received between Aug 6, 2018 and Aug 6, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2018Incomplete Coaptation; Defective Device; Patient Device Interaction Problem; Incomplete Coaptation; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 9 MONTHS POST IMPLANT OF THIS 27 MM MITRAL MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED. AN ECHOCARDIOGRAM SHOWED THAT THE ANTERIOR LEAFLET APPEARED TO BE FIXED, WHICH CAUSED MITRAL INSUFFICIENCY AND STENOSIS AT THE PERIPHERY OF THE VALVE. THE VALVE WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH A BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Corneal Pannus; Mitral Insufficiency; Mitral Valve Stenosis; Stenosis

  MAUDE report 7754084 ↗

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