Open Pivot™ 500DM31 (UDI 00613994868985)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994868985), received between Jul 5, 2024 and Apr 27, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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 3 most recent of 3 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 24999623 ↗
• InjuryApr 28, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR REPLACEMENT WAS SEVERE MITRAL STENOSIS. IT WAS STATED THAT THE MITRAL VALVE WAS THROMBOSED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Stenosis; Thrombosis/Thrombus

  MAUDE report 21917042 ↗
• InjuryJul 5, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 31MM MITRAL MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Low Blood Pressure/ Hypotension; Pseudoaneurysm

  MAUDE report 19678857 ↗

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