Open Pivot™ 505DA22 (UDI 00613994959973)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994959973), received between Dec 2, 2016 and May 6, 2025 — 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.

• InjuryMay 6, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT POST IMPLANT OF THIS 22MM AORTIC MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AVALUS VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21967618 ↗
• InjurySep 13, 2024Perivalvular Leak; Insufficient Device Problem Information; Perivalvular Leak; Insufficient Device Problem Information

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REASON FOR THE REPLACEMENT WAS SEVERE PARAVALVULAR LEAK (PVL). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Valvular Insufficiency/ Regurgitation

  MAUDE report 20214703 ↗
• InjuryMar 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 22MM AORTIC MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9878773 ↗
• InjuryFeb 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT TWO YEARS POST IMPLANT OF THIS 22MM MECHANICAL AORTIC VALVE, THIS DEVICE WAS EXPLANTED AND REPLACED WITH A 22MM MECHANICAL AORTIC VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6293025 ↗
• InjuryDec 2, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT TWO YEARS, TEN MONTHS POST IMPLANT OF THIS AORTIC MECHANICAL VALVE, THE DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; No Information

  MAUDE report 6142269 ↗

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