FREESTYLE® FR995-29 (UDI 00643169008144)Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 00643169008144), received between Dec 21, 2016 and Sep 18, 2026 — classified as 6 deaths, 107 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (61 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Insufficient Device Problem Information

  Medtronic received information that approximately 11 years post implant of this 29mm aortic bioprosthetic 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: Insufficient Information

  MAUDE report 50815200 ↗
• MalfunctionSep 15, 2026Insufficient Device Problem Information

  It was reported that 13 years and 4 months post implant of this 29mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was not reported. Evidence of calcification was seen in the Sino-tubular junction (STJ) and in ascending aorta. No intervention or adverse patient effects were reported.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 50768094 ↗
• InjuryAug 4, 2026Patient Device Interaction Problem; Intravalvular regurgitation

  Additional information was received that the patient successfully had a 34mm aortic transcatheter valve-in-valve replacement. No additional adverse patient effects were reported.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Chest Pain; Dizziness; Dyspnea

  MAUDE report 50135395 ↗
• InjuryJul 28, 2026Patient Device Interaction Problem

  Medtronic received information that 3 years and 4 months post implant of this 29mm Freestyle heart valve, a Bi-Ventricular Defibrillator was implanted. The reason for the Bi-Ventricular Defibrillator was  reported as low ejection fraction (EF) and complete heart block (CHB). No additional adverse patient effects were reported.

  Patient problems: Heart Block

  MAUDE report 50059145 ↗
• DeathMay 21, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE AND 27MM MITRAL BIOPROSTHETIC VALVE, THE PATIENT WAS REPORTED DECEASED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE VALVES COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 25239566 ↗
• InjuryApr 27, 2026Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 7 YEARS AND 3 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC CENTRAL REGURGITATION, AORTIC STENOSIS, HEART FAILURE AND HEMODYNAMIC INSTABILITY. SUBSEQUENTLY ON (B)(6) 2026 THE PATIENT SUCCESSFULLY HAD A 29MM AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure

  MAUDE report 24999349 ↗
• InjuryFeb 20, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 13 YEARS AND 4 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC CENTRAL REGURGITATION. SUBSEQUENTLY ON (B)(6) 2026, THE PATIENT SUCCESSFULLY HAD A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24400091 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED 5 YEARS AND 5 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM AORTIC BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24376191 ↗
• InjuryFeb 16, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 13 YEARS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC CENTRAL REGURGITATION. EVIDENCE OF CALCIFICATION WAS SEEN IN THE AORTIC ROOT AND ASCENDING AORTA. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 24344899 ↗
• InjuryFeb 11, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 10 YEARS AND 10 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC CENTRAL REGURGITATION. IT WAS REPORTED THAT AN INTERVENTION IS REQUIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 24313698 ↗
• InjuryFeb 6, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT 11 YEARS AND 10 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, 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: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 24277884 ↗
• InjuryJan 26, 2026Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 3 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24184405 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 12 YEARS AND 9 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM AORTIC BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24093826 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 5 YEARS AND 4 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AORTIC BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23972193 ↗
• InjuryDec 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 11 YEARS AND 10 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY 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; Cardiomyopathy; Tachycardia

  MAUDE report 23888838 ↗
• InjuryNov 7, 2025Device Stenosis; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT ON (B)(6) 2025, THE PATIENT SUCCESSFULLY HAD A 34MM TRANSCATHETER VALVE IMPLANTED VAL VE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 23497408 ↗
• InjuryOct 29, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT 13 YEARS AND 11MONTH POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT OR A REDO SURGICAL AORTIC VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS CENTRAL AORTIC REGURGITATION. IT WAS REPORTED THAT AN INTERVENTION WAS PLANNED, NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 9 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23415669 ↗
• InjuryAug 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN UNKNOWN DURATION POST IMPLANT OF THIS FREESTYLE AORTIC VALVE, A COMPETITORS 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 22841453 ↗
• InjuryAug 19, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 8 MONTHS POST IMPLANT OF THIS 29MM FREESTYLE AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC REGURGITATION (AR). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22837029 ↗
• InjuryAug 13, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS POST IMPLANT OF THIS 29MM FREESTYLE AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A T RANSCATHETER VALVE-IN-VALVE REPLACEMENT OR RE-DO SURGERY. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC REGURGITATION (AR). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 3 DAYS LATER, THE FREESTYLE VALVE WAS EXPLANTED AND REPLAC ED WITH A 29MM AVALUS VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22793748 ↗
• InjuryJul 2, 2025Perivalvular Leak; Intravalvular regurgitation; Perivalvular Leak; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 3 MONTHS POST IMPLANT OF THIS 29MM FREESTYLE AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS REGURGITATION. EVIDENCE OF ANNULAR CALCIFICATION SEEN UNDER THE RIGHT CORONARY CUSP (RCC) AND CALCIFICATION SEEN IN THE ASCENDING AORTA. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 22380473 ↗
• MalfunctionJun 25, 2025Calcified; Device Stenosis; Calcified; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 19 YEARS AND 2 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVAL UATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. IT WAS REPORTED THAT ON EVALUATION, CALCIUM WAS DISCOVERED UNDER ALL THE LEAFLETS EXTENDING INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT), IN THE SINUSES OF VALSALVA, IN THE SINOTUBULAR JUNCTION AND ASCENDING AORTA. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 22330495 ↗
• MalfunctionJun 23, 2025Degraded; Degraded

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 7 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. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22310268 ↗
• InjuryJun 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 6 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22237186 ↗
• InjuryJun 3, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 5 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 SEVERE AORTIC REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22133400 ↗