FREESTYLE® FR995-23 (UDI 00643169002135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00643169002135), received between Feb 24, 2017 and Sep 29, 2026 — classified as 8 deaths, 58 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (41 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 72 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Insufficient Device Problem Information

  Medtronic received information that 3 years 3 month post implant of this 23mm aortic bioprosthetic valve, the patient was being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was not reported. It was reported that an intervention was required. No additional adverse patient effects were reported.

  Patient problems: Insufficient Information

  MAUDE report 50929371 ↗
• MalfunctionSep 25, 2026Device Stenosis

  Medtronic received information that 7 years and 7 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 aortic valve stenosis (AS). No intervention or additional adverse patient effects were reported.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50894945 ↗
• DeathJul 28, 2026Insufficient Device Problem Information

  Medtronic received information that 5 days post implant of this 23mm aortic aortic bioprosthetic valve, the patient died. The cause of death was not received. Therefore, relatedness of the death to the valve can not be excluded. It is unknown whether an autopsy was performed.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50051475 ↗
• MalfunctionApr 24, 2026Thickening of Material

  IT WAS REPORTED THAT POST IMPLANT OF THIS FREESTYLE 23MM AORTIC BIOPROSTHETIC VALVE, AN ECHOCARDIOGRAM PERFORMED NOTED LEAFLET THICKENING. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24982717 ↗
• InjuryJan 12, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 3 DAYS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC 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 24034744 ↗
• InjuryJan 5, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REASON FOR INTERVENTION AS SEVERE AORTIC REGURGITATION (AR). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 23956308 ↗
• InjuryDec 22, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 8 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. SUBSEQUENTLY, 8 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23871321 ↗
• InjuryDec 15, 2025Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A 23MM FREESTYLE AORTIC VALVE WAS IMPLANTED IN THE PULMONARY POSITION DURING A PROCEDURE. HIGH PRESSURES AND A HIGH GRADIENT WERE OBSERVED THROUGH THE VALVE, AND THE SURGEON WAS NOT SATISFIED WITH THE VALVE'S PERFORMANCE. THE VALVE WAS EXPLANTED AND REPLACED WITH A 29MM AVALUS VALVE, WHICH WAS SEWN INTO A 32MM GRAFT IN THE PULMONARY POSITION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23803452 ↗
• InjuryDec 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 8 YEARS AND 7 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A 26MM 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 23800692 ↗
• MalfunctionNov 6, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT 9 YEARS AND 9 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. NO INTERVENTION OR ADDITIONAL PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 23486246 ↗
• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23278518 ↗
• InjuryAug 19, 2025Perivalvular Leak; Intravalvular regurgitation; Perivalvular Leak; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 11 MONTHS POST IMPLANT OF THIS 23MM FREESTYLE AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVER AORTIC REGURGITATION (AR), PARAVALVULAR LEAK (PVL) AND AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22837748 ↗
• InjuryAug 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 9 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM 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 22786257 ↗
• InjuryAug 11, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 5 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 REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22771652 ↗
• InjuryJun 10, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 8 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. IT WAS ALSO REPORTED THAT DURING EVALUATION, CALCIUM COULD BE SEEN IN THE PROXIMAL RIGHT CORONARY ARTERY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 22176384 ↗
• InjuryApr 30, 2025Device Stenosis; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT 4 MONTHS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21937656 ↗
• InjuryMar 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS VALVE FR995-23 FREESTYLE AORTIC 23MM, THE PATIENT SUFFERED A POSTOPERATIVE CEREBROVASCULAR ACCIDENT WITH LEFT SIDED WEAKNESS WHICH SLOWLY RESOLVED OVERTIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 21730030 ↗
• DeathFeb 18, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DIED AT HOME AND THE CAUSE OF DEATH WAS REPORTED AS CHRONIC SYSTOLIC HEART FAILURE. IT WAS STATED THAT THE PHYSICIAN DOES NOT BELIEVE THE MEDTRONIC PRODUCT CAUSED OR CONTRIBUTED TO DEATH AND NO AUTOPSY WAS PERFORMED.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 21403522 ↗
• InjuryJan 16, 2025Insufficient Device Problem Information; Thickening of Material; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Thickening of Material; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR REPLACEMENT WAS SEVERE AORTIC INSUFFICIENCY AND STENOSIS. IT WAS REPORTED THAT PRIOR TO EXPLANT, THE PATIENT EXPERIENCED SHORTNESS OF BREATH WITH ACTIVITY AND COMPLAINED OF SIGNIFICANT FATIGUE. IT WAS REPORTED THAT DURING THE EXPLANT PROCEDURE, IT WAS NOTED THAT THE 23MM AORTIC BIOPROSTHETIC VALVE WAS THICKENED WITH TEARS OF THE LEAFLETS AND THERE WAS MINIMAL PANNUS INGROWTH UNDERNEATH THE AORTIC ANNULUS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21168639 ↗
• InjuryJan 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 23MM FREESTYLE AORTIC VALVE IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE RE PLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. IT WAS NOTED THAT THE PATIENT HAD BEEN HOSPITALIZED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: Insufficient Information

  MAUDE report 21114188 ↗
• InjuryJan 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM 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 21113657 ↗
• InjuryJan 3, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 8 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 NOTED THAT THERE IS CALCIFICATION IN THE LEFT CORONARY ARTERY AND CONCENTRIC CALCIFICATION IN THE SINOTUBULAR JUNCTION (STJ).NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 21067902 ↗
• MalfunctionNov 21, 2024Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 10 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 REPORTED AS AORTIC STENOSIS AND ELEVATED GRADIENTS OF 42MMHG. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 20754158 ↗
• InjuryNov 14, 2024Insufficient Device Problem Information; Material Split, Cut or Torn; Intravalvular regurgitation; Insufficient Device Problem Information; Material Split, Cut or Torn; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 3 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cusp Tear; Insufficient Information

  MAUDE report 20685222 ↗
• MalfunctionNov 14, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 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 AORTIC REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20681105 ↗