3f® 1000-29 (UDI 00613994959720)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994959720), received between Jan 18, 2019 and Sep 29, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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.

• InjurySep 29, 2026Insufficient Device Problem Information

  Medtronic received information that 14 years and 3 months post implant of this 29mm aortic mechanical valve, a 29mm aortic transcatheter valve was implanted valve-in-valve. The reason for intervention was not reported. No additional adverse patient effects were reported.

  Patient problems: Insufficient Information

  MAUDE report 50928914 ↗
• InjuryJan 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT SEVEN YEARS AND ONE MONTH POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A NON-MEDTRONIC TRANS CATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE VALVE WAS REPLACED DUE TO STENOSIS AND REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Regurgitation; Aortic Valve Stenosis

  MAUDE report 8260289 ↗