FREESTYLE® FR995-23 (UDI 00681490265904)Recalls & reported problems

Summary

The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 00681490265904), received between Aug 4, 2017 and Apr 14, 2026 — classified as 188 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (143 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 192 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Patient Device Interaction Problem; Device Stenosis

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR EVALUATION WAS STENOSIS. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification; Heart Failure/Congestive Heart Failure

  MAUDE report 24870347 ↗
• InjuryMar 19, 2026Gradient Increase; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 11 YEARS AND 5 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. EVIDENCE OF HEAVY CALCIFICATION WAS SEEN IN THE SINO-TUBULAR JUNCTION (STJ). IT WAS REPORTED THAT AN INTERVENTION IS REQUIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 24638555 ↗
• InjuryMar 5, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT 13 YEARS AND 2 MONTHS POST IMPLANT OF THIS 23MM 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; Insufficient Information

  MAUDE report 24519699 ↗
• InjuryNov 11, 2025Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 16 YEARS AND 10 MONTHS POST IMPLANT OF THIS 23MM FREESTYLE AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS CARDIOGENIC SHOCK AND CONGESTIVE HEART FAILURE (CHF) WHICH RESULTED IN REHOSPITALIZATION. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23523312 ↗
• InjuryAug 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 9 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22770389 ↗
• InjuryJul 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 6 MONTHS POST IMPLANT OF THIS FREESTYLE VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 22641609 ↗
• InjuryMay 28, 2025Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 11 MONTHS POST IMPLANT OF THIS 23MM FREESYLE AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC REGURGITATION AND HEMODYNAMIC INSTABILITY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22095182 ↗
• InjuryMay 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 19 YEARS AND 7 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22010650 ↗
• InjuryMar 13, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS SEVERE AORTIC REGURGITATION. IT WAS ALSO REPORTED THAT THE PATIENT HAD SYMPTOMS OF FATIGUE AND SHORTNESS OF BREATH, INCLUDING SYNCOPAL EPISODES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Fatigue; Insufficient Information; Syncope/Fainting

  MAUDE report 21597228 ↗
• InjuryFeb 26, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 14 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 NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 19 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY (AI). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21472093 ↗
• InjuryFeb 10, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE REASON FOR EVALUATION WAS AORTIC REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21345550 ↗
• InjuryJan 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF A FREESTYLE BIOPROSTHETIC VALVE IN THE PULMONARY POSITION, IT WAS EXPLANTED AND REPLACED WITH ANOTHER FREESTYLE BIOPROSTHETIC VALVE IN THE PULMONARY POSITION. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21206176 ↗
• InjuryJan 14, 2025Gradient Increase; Insufficient Device Problem Information; Thickening of Material; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Insufficient Device Problem Information; Thickening of Material; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 18 YEARS AND 8 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 REVEALED ON EVALUATION THAT CALCIUM COULD BE SEEN UNDER THE LEFT CORONARY CUSP (LCC), IN THE SINOTUBULAR JUNCTION AND A POSSIBLE THROMBUS ON THE LEFT ATRIAL AP PENDAGE (LAA). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Calcium Deposits/Calcification; Insufficient Information; Thrombosis/Thrombus

  MAUDE report 21150246 ↗
• MalfunctionDec 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 16 YEARS AND 8 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 DURING EVALUATION THAT CALCIUM COULD BE SEEN IN THE SINOTUBULAR JUNCTION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 20844708 ↗
• InjuryNov 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS ENDOCARDITIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis

  MAUDE report 20738084 ↗
• MalfunctionNov 14, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 16 YEARS AND 6 MONTHS POST IMPLANT OF THIS 23MM 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, A MOBILE ECHODENSITY CONSISTENT WITH A PROLAPSED AORTIC VALVE LEAFLET WITH A MOBILE MASS ATTACHED POSSIBLY DUE TO VEGETATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20681208 ↗
• MalfunctionNov 8, 2024Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 23 YEARS AND 4 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC STENOSIS (AS) AND MILD AORTIC INSUFFICIENCY (AI) WITH A MEAN GRADIENT OF 55.6MMHG. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20645824 ↗
• InjuryOct 31, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 14 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. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 20579095 ↗
• InjuryOct 23, 2024Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION WHICH STATED THAT THE REASON FOR INTERVENTION WAS REPORTED AS MODERATE TO SEVERE AORTIC REGURGITATION (AR) AND AORTIC STENOSIS (AS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20512473 ↗
• InjuryOct 15, 2024Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Intravalvular regurgitation; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 13 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 Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 20449222 ↗
• MalfunctionOct 11, 2024Calcified; Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Calcified; Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REASON FOR INTERVENTION WAS AORTIC STENOSIS (AS) AND INCREASED GRADIENTS. IT WAS STATED THAT THE PATIENT IS BEING CONSIDERED FOR A REDO SURGICAL AORTIC VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Calcium Deposits/Calcification; Chest Pain; Pleural Effusion

  MAUDE report 20429410 ↗
• InjuryOct 2, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT 13 YEARS AND 8 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A AORTIC MECHANICAL VALVE OF A DIFFERENT MANUFACTURER. IT WAS STATED THAT THE PATIENT HAD BEEN EXPERIENCING PROGRESSIVE SHORTNESS OF BREATH (SOB). THE PATIENT DEVELOPED ATRIAL FIBRILLATION (AFIB) WITH RAPID VENTRICULAR RESPONSE (RVR) AND WAS ADMITTED TO HOSPITAL. IT WAS REVEALED THAT THERE WAS MODERATE TO SEVERE AORTIC STENOSIS (AS) OF THE VALVE WITH SUSPECTED VEGETATION ON AN AORTIC LEAFLET AND SEVERE AORTIC INSUFFICIENCY (AI). IT WAS NOTED DURING EXPLANT THAT THERE WAS A LOT OF CALCIFICATIONS IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Atrial Fibrillation; Calcium Deposits/Calcification; Dyspnea; Insufficient Information

  MAUDE report 20351837 ↗
• InjurySep 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 4 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A REPLACEMENT PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 20198713 ↗
• InjurySep 11, 2024Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 19 YEARS AND 4 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 AORTIC STENOSIS, A MEAN PRESSURE GRADIENT OF 41MMHG AND TRACE AORTIC INSUFFICIENCY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20196041 ↗
• InjuryAug 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION 13 YEARS AND 4 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT HAD PERMANENT ATRIAL FIBRILLATION. MEDICATION WAS PRESCRIBED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 19996604 ↗