3f® 1000-21 (UDI 00613994868220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00613994868220), received between Jul 25, 2017 and Jun 25, 2025 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2025Calcified; Intravalvular regurgitation; Calcified; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 11 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. IT WAS DISCOVERED ON EVALUATION THAT CALCIUM WAS SEEN UNDER THE LEFT CORONARY CUSP IN THE LEFT VENTRICULAR OUTFLOW TRACT, PROTRUDING CALCIUM IN THE ASCENDING AORTA AND ABDOMINAL AORTA. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 7 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC INSUFFICIENCY AND CALCIFICATION OF THE VALVE LEAFLETS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Calcium Deposits/Calcification

  MAUDE report 22328152 ↗
• InjuryApr 30, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 7 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS MILD TO MODERATE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21935436 ↗
• MalfunctionJun 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION 10 YEARS AND 7 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE THAT THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19482687 ↗
• InjuryJun 5, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 3 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC INSUFFICIENCY (AI). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19470533 ↗
• InjuryJan 5, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT AFTER AN UNKNOWN DURATION POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 18452315 ↗
• InjuryJun 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 11 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, A NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 14788176 ↗
• InjuryDec 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 9 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Insufficient Information

  MAUDE report 12909031 ↗
• InjuryDec 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 5 MONTHS POST IMPLANT OF THIS 21MM BIOPROSTHETIC AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 11065059 ↗
• InjuryMay 4, 2020Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 11 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency; No Information

  MAUDE report 10021895 ↗
• InjuryFeb 3, 2020Adverse 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 8 YEARS AND 2 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 21MM AORTIC ROOT BIOPROSTHESIS. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Abscess; No Information

  MAUDE report 9662558 ↗
• InjuryNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 3 MONTHS POST IMPLANT OF THIS 21MM BIOPROSTHETIC AORTIC VALVE, THE PATIENT WAS EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT DUE TO SEVERE INSUFFICIENCY. THE PATIENT WAS DETERMINED TO NOT BE A CANDIDATE FOR TRANSCATHETER VALVE REPLACEMENT. NO KNOWN INTERVENTION HAS OCCURRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY 7 YEARS AND 7 MONTHS POST IMPLANT OF THIS 21MM BIOPROSTHETIC AORTIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 21MM VALVE OF A DIFFERENT MODEL DUE TO SEVERE INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency

  MAUDE report 9309948 ↗
• InjuryOct 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS 11 MONTHS POST IMPLANT OF THIS 21MM BIOPROSTHETIC AORTIC VALVE, A 23MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. IT WAS REPORTED THAT THE VALVE WAS SEVERELY STENOTIC, WITH AN AORTIC VALVE AREA OF 0.4CM². NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 9186840 ↗
• InjuryMay 16, 2019Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn

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

  Patient problems: Aortic Valve Stenosis; Cusp Tear; Fibrosis; No Information

  MAUDE report 8617259 ↗
• InjuryNov 26, 2018Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT NINE YEARS AND EIGHT MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; No Information

  MAUDE report 8102093 ↗
• InjurySep 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS 3 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE DEVICE WAS EXPLANTED AND REPLACED WITH A MECHANICAL VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6897656 ↗
• InjuryJul 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS 5 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE DEVICE WAS REPLACED VALVE-IN-VALVE WITH A MEDTRONIC TRANSCATHETER VALVE DUE TO AORTIC STENOSIS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 6739618 ↗