Open Pivot™ 505DA26Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169334984), received between Jan 18, 2018 and Jun 22, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2021Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 26MM AORTIC MECHANICAL VALVE WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12044310 ↗
• InjuryJan 18, 2018Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 1 MONTH POST IMPLANT OF THIS AORTIC MECHANICAL VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; No Information

  MAUDE report 7203756 ↗

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