3f® 1000-27 (UDI 00613994868251)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994868251), received between Oct 31, 2019 and Jun 23, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Gradient Increase” (1 report).

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 18, 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 23, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 8 MONTHS POST IMPLANT OF THIS 27MM 3F AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC INSUFFICICENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22306227 ↗
• InjuryOct 31, 2019Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 6 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT UNDERWENT A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT DUE TO INCREASED GRADIENTS AND MODERATE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Regurgitation

  MAUDE report 9262231 ↗