Open Pivot™ 501DM26Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169334823), received between Dec 1, 2016 and Dec 1, 2016 — classified as 1 death.

The most frequently reported specific device problem is “Mechanical Jam” (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.

• DeathDec 1, 2016Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS MECHANICAL MITRAL VALVE, THE PHYSICIAN WAS UNABLE TO ROTATE THE DEVICE INTO AN ANT-ANATOMICAL POSITION AFTER A CONSIDERABLE AMOUNT OF TIME AND EFFORT. AFTER THE HEART WAS CLOSED AND WHILE ATTEMPTING TO WEAN THE PATIENT OFF OF CARDIOPULMONARY BYPASS (CPB), A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED THAT ONE OF THE MITRAL VALVE LEAFLETS WAS NOT MOVING, RESULTING IN SEVERE REGURGITATION. THE PATIENT WAS RETURNED TO CPB, AND THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO ROTATE THE DEVICE INTO A MORE OPTIMAL POSITION. THE PHYSICIAN EXPLANTED THE DEVICE, DEBRIDED THE ANNULUS OF EXCESS TISSUE, AND IMPLANTED A 24MM MECHANICAL VALVE. POST-OPERATIVELY, THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND TRANSFERRED TO THE INTENSIVE CARE UNIT. TWO DAYS LATER, THE PATIENT DIED.

  Patient problems: Mitral Regurgitation

  MAUDE report 6139699 ↗

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