Open Pivot™ 501DM24Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994960368), received between Dec 1, 2016 and Jul 14, 2019 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Gradient Increase” (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.

• InjuryJul 14, 2019Gradient Increase; Incomplete Coaptation; Gradient Increase; Incomplete Coaptation

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 11 MONTHS POST IMPLANT OF THIS 24MM MITRAL MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE. THE VALVE WAS REPLACED DUE TO PANNUS FORMATION WHICH WAS REPORTED TO CAUSE SEVERE STENOSIS OF THE PROSTHETIC VALVE. ADDITIONALLY, IT WAS NOTED THAT THE POSTERIOR LEAFLET WAS FIXED AND A 14MMHG GRADIENT WAS PRESENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Corneal Pannus; Mitral Valve Stenosis

  MAUDE report 8787640 ↗
• DeathDec 1, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING IMPLANT OF THIS BIOPROSTHETIC VALVE, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED MODERATE REGURGITATION. THE RIGHT VENTRICLE WAS ALSO COMPLETELY IMMOBILE. A BALLOON PUMP WAS IMPLANTED, BUT THE HEART SHOWED NO IMPROVEMENT. 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 6139743 ↗

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