Open Pivot™ 500DM27 (UDI 00613994868961)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994868961), received between Nov 3, 2017 and Apr 27, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 12 YEARS AND 1 MONTH POST IMPLANT OF THIS 27MM TRICUSPID MECHANICAL VALVE AND 31MM MITRAL MECHANICAL VALVE, A LEADLESS PACEMAKER WAS IMPLANTED. THE REASON FOR THE LEADLESS PACEMAKER WAS REPORTED AS ATRIOVENTRICULAR BLOCK (AVB) (MOBITZ II). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24999620 ↗
• InjuryJun 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 WEEKS POST IMPLANT OF THIS 20MM AORTIC MECHANICAL VALVE AND 27MM MITRAL MECHANICAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS) AND SECOND DEGREE ATRIO-VENTRICULAR BLOCK (AVB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 19457750 ↗
• InjuryApr 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 11 MONTHS POST IMPLANT OF THIS 27MM MITRAL MECHANICAL VALVE, IT WAS EXPLANTED AND RE PLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14209500 ↗
• InjuryNov 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 59 MONTHS POST IMPLANT OF THIS MECHANICAL VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A BIO PROSTHETIC VALVE DUE TO THROMBOSIS. THE PHYSICIAN REPORTED THERE WAS NO VALVE FAILURE BUT THE PATIENT WAS NOT BEING COMPLIANT WITH ANTICOAGULANT THERAPY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Thrombosis

  MAUDE report 6999665 ↗

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