Open Pivot™ 500DM27 (UDI 00643169977754)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169977754), received between Dec 4, 2023 and Feb 21, 2025 — 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.

• InjuryFeb 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 27MM MITRAL MECHANICAL VALVE AND 10 YEARS AND 8 MONTHS POST IMPLANT OF THIS 25MM TRICUSPID ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEIZURE ACTIVITY AND A STROKE. A COMPUTED TOMOGRAPHY (CT) OF THE HEAD DEMONSTRATED NO ACUTE PROCESS. AN ELECTROENCEPHALOGRAPHY SHOWED STATUS EPILEPTICUS AND A ANTI-EPILEPTIC DRUG WAS ADMINISTERED. IT WAS STATED THAT THE COMPUTED TOMOGRAPHY (CT) SHOWED THE PRESENCE OF A RIGHT M2 BRANCH OCCLUSION, A RELATIVELY SMALL BRANCH DISTAL TO A TRIFURCATION OF THE MIDDLE CEREBRAL ARTERY (MCA), WITH IMMEDIATE DISTAL RECONSTITUTION AND SHOWED A REGION OF MODERATE STENOSIS OF RIGHT M2 BRANCHES WITH POST-STENOTIC DILATATION. AN MAGNETIC RESONANCE IMAGING (MRI) OF THE HEAD WAS OBTAINED THE FOLLOWING DAY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Convulsion/Seizure; Stroke/CVA

  MAUDE report 21433222 ↗
• InjuryDec 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF THIS 27MM MITRAL MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18263421 ↗

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