Open Pivot™ 505DA22 (UDI 00643169335004)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169335004), received between May 12, 2021 and Sep 23, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Patient Device Interaction Problem

  It was reported that 3 years and 4 months post implant of this 22mm aortic open pivot valve, a permanent pacemaker was implanted. The reason for the permanent pacemaker was reported as complete heart block (CHB) and atrial arrythmias (atrial tachycardia (AT), atrial fibrillation (AF) and atrial flutter (A-Fl). No additional adverse patient effects were reported.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Heart Block; Tachycardia

  MAUDE report 50867293 ↗
• InjuryFeb 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 1 MONTHS POST IMPLANT OF THIS 22MM AORTIC MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A VALVE OF A DIFFERENT MANUFACTURER. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18696880 ↗
• InjuryMay 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 DAYS POST IMPLANT OF THIS 22MM AORTIC MECHANICAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK. IT WAS REPORTED THAT THIS WAS DUE TO THE COMPLEX NATURE OF THE PATIENT'S ANATOMY WHICH REQUIRED AUGMENTATION TO UPSIZE THE AORTIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 14341017 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 22MM AORTIC MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11893119 ↗
• InjuryMay 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS 5 DAYS POST IMPLANT OF THIS 22MM AORTIC MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM AORTIC BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11811572 ↗

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