FREESTYLE® FR99525Recalls & reported problems

Summary

The FDA's MAUDE database contains 280 adverse event reports that list this exact device (DI 10681490265918), received between Mar 23, 2017 and Sep 25, 2026 — classified as 2 deaths, 270 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (213 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 280 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Insufficient Device Problem Information

  Medtronic received information that 14 years and 9 months post implant of this 25mm 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 50895043 ↗
• InjuryApr 27, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 14 YEARS AND 11 MONTHS POST IMPLANT OF THIS 25 MM 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 MODERATE AORTIC CENTRAL REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24999305 ↗
• InjuryApr 3, 2026Gradient Increase; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 15 YEARS AND 4 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS TRIVIAL AORTIC REGURGITATION, AORTIC STENOSIS, AND AN INCREASED MEAN GRADIENT OF 35MMHG. AN TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IS SCHEDULED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 24779616 ↗
• InjuryMar 18, 2026Gradient Increase; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REASON FOR THE INTERVENTION WAS HIGH GRADIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 24625796 ↗
• InjuryMar 9, 2026Calcified; Material Split, Cut or Torn; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 7 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 REPORTED AS SEVERE AORTIC REGURGITATION AND A TORN LEAFLET. IT WAS FURTHER NOTED THAT CALCIUM WAS PRESENT IN THE PROXIMAL LEFT CORONARY ARTERY (LCA). THE PATIENT HAS BEEN RE-HOSPIT ALIZED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 24551954 ↗
• InjuryDec 22, 2025Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 10 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVA LUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC INSUFFICIENCY. IT WAS FURTHER NOTED THAT THE PATIENTS HOSPITALIZATION WAS PROLONGED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 2 D AYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS ALSO REPORTED AS POOR COAPTATION OF THE VALVE LEAFLETS. THE PATIENT ALSO HAD SYMPTOMS OF SHORTNESS OF BREATH AND FATIGUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Fatigue

  MAUDE report 23872652 ↗
• InjuryNov 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 17 YEARS AND 3 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIAL ARRYTHMIAS (ATRIAL TACHYCARDIA (AT), ATRIAL FIBRILLATION (AF), AND ATRIAL FLUTTER (A-FL)). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia; Atrial Fibrillation; Atrial Flutter; Tachycardia

  MAUDE report 23495773 ↗
• InjuryNov 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 15 YEARS AND 9 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. IT WAS REPORTED AN INTERVENTION WAS REQUIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23475155 ↗
• InjuryOct 15, 2025Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 10 MONTHS POST IMPLANT OF THIS 25MM FREESTYLE AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS CONGESTIVE HEART FAILURE (CHF) WHICH RESULTED IN RE-HOSPITALIZATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23289309 ↗
• InjuryAug 13, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS POST IMPLANT OF THIS 25MM FREESTYLE AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED V ALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC REGURGITATION (AR). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22791275 ↗
• InjuryJul 3, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 17 YEARS POST IMPLANT OF THIS FREESTYLE AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANS CATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS REGURGITATION. IT WAS REPORTED THAT CALCIUM WAS NOTED IN THE PROXIMAL LEFT CORONARY ARTERY AND RIGHT CORONARY ARTERY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 22393527 ↗
• InjuryJun 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 3 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME OR SINUS NODE DYSFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22196978 ↗
• InjuryJun 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 8 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME OR SINUS DYSFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22196831 ↗
• InjuryJun 3, 2025Calcified; Device Stenosis; Calcified; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 19 YEARS AND 1 MONTH 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 STENOSIS. IT WAS ALSO REPORTED THAT ON EVALUATION, CALCIUM COULD BE SEEN IN THE SINOTUBULAR JUNCTION. AN INTERVENTION IS REQUIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 11 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22136276 ↗
• InjuryMay 22, 2025Calcified; Insufficient Device Problem Information; Intravalvular regurgitation; Calcified; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 16 YEARS AND 2 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 REPORTED THAT DURING THE EVALUATION, CALCIUM COULD BE SEEN IN THE PROXIMAL RIGHT CORONARY ARTERY AND IN THE SINOTUBULAR JUNCTION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 22073215 ↗
• MalfunctionMay 15, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 17 YEARS AND 7 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 CALCIUM COULD BE SEEN UNDER THE LEFT CORONARY CUSP IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 22031010 ↗
• InjuryMay 15, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT POST IMPLANT OF THIS FREESTYLE AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS MODERATE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22027798 ↗
• MalfunctionMay 14, 2025Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 25 YEARS AND 3 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 NOTED THAT CALCIUM COULD BE SEEN IN THE SINOTUBULAR JUNCTION AND THE PROXIMAL RIGHT CAROTID ARTERY, AS WELL AS POSSIBLE PANNUS OR THROMBUS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification; Foreign Body Reaction; Insufficient Information; Thrombosis/Thrombus

  MAUDE report 22019878 ↗
• InjuryFeb 10, 2025Calcified; Insufficient Device Problem Information; Intravalvular regurgitation; Calcified; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 25 YEARS AND 6 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 REPORTED THAT DURING EVALUATION, CALCIUM COULD BE SEEN IN THE SINOTUBULAR JUNCTION AND UNDER THE NON CORONARY CUSP (NCC) EXTENDING INTO THE LEFT VALVE OUTFLOW TRACT (LVOT). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21347360 ↗
• InjuryFeb 10, 2025Calcified; Gradient Increase; Device Stenosis; Intravalvular regurgitation; Calcified; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT 19 DAYS LATER, THE PATIENT SUCCESSFULLY HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS, SEVERE AORTIC INSUFFICIENCY AND MEAN GRADIENT OF 31MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21342038 ↗
• InjuryFeb 10, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A FREESTYLE AORTIC VALVE WAS EXPERIENCING SEVERE CENTRAL AORTIC REGURGITATION. THE PATIENT HAD THE MEDTRONIC VALVE REPLACED WITH A 26MM AORTIC TRANSCATHETER VALVE OF A DIFFERENT MANUFACTURER IN APRIL 2017. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21341949 ↗
• MalfunctionJan 29, 2025Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 19 YEARS AND 3 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS GRADIENT INCREASE. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21267938 ↗
• MalfunctionJan 21, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 13 YEARS AND 3 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS AND INCREASED GRADIENTS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21195463 ↗
• InjuryJan 7, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT AFTER AN UNKNOWN DURATION POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A DIFFERENT MANUFACTURERS PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 21097143 ↗
• MalfunctionNov 13, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED TO BE ADEQUATE VALVE GRADIENTS OF A PEAK AT 33MMHG AND A MEAN OF 20MMHG, SEVERE AORTIC REGURGITATION AND MILD AORTIC STENOSIS. IT WAS NOTED THAT LEAFLET MOTION IS MILDLY RESTRICTED AND THERE IS AN PROLAPSE OF ONE OF THE LEAFLETS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20678219 ↗