FREESTYLE® FR995-29 (UDI 00681490816465)Recalls & reported problems

Summary

The FDA's MAUDE database contains 288 adverse event reports that list this exact device (DI 00681490816465), received between Jul 24, 2017 and Jun 19, 2026 — classified as 283 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (204 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 288 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 29 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: Insufficient Information

  MAUDE report 25564155 ↗
• InjuryFeb 9, 2026Incomplete Coaptation

  IT WAS REPORTED THAT 17 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 POOR COAPTATION OF THE VALVE LEAFLETS. IT WAS REPORTED THAT AN INTERVENTION IS REQUIRED AND PLANNED FOR (B)(6) 2026. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24289834 ↗
• InjuryJan 28, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 14 YEARS AND 7 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS LOW EJECTION FRACTION (EF) 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; Tachycardia

  MAUDE report 24199741 ↗
• InjuryJan 8, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR INTERVENTION WAS MODERATE AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 24001134 ↗
• InjuryJan 6, 2026Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23973724 ↗
• InjuryOct 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 3 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM 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 23341461 ↗
• InjuryOct 16, 2025Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION REPORTED THE LEVEL OF REGURGITATION AS SEVERE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23315962 ↗
• InjurySep 12, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 14 YEARS AND 11 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, A 34MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC REGURGITATION AND STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23037162 ↗
• InjurySep 8, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 10 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 22992526 ↗
• MalfunctionAug 14, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 1 MONTH 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 POSSIBLE THROMBUS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22803400 ↗
• InjuryJun 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SINUS BRADYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 22318386 ↗
• InjuryJun 16, 2025Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 21 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 SEVERE AORTIC INSUFFICIENCY DUE TO A TORN LEAFLET. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 1 DAY LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cusp Tear

  MAUDE report 22214639 ↗
• MalfunctionJun 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 11 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 NOT REPORTED. EVIDENCE OF CALCIFICATION IN THE SINOTUBULAR JUNCTION (STJ) AND POSSIBLE ANEURYSMAL BULGE IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) UNDER THE NON-CORONARY CUSP (NCC). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 22166014 ↗
• InjuryMay 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN EXPLANT OF AN EXISTING AORTIC VALVE AND THE IMPLANT OF A NEW AORTIC VALVE OCCURRED. THE EXISTING AORTIC VALVE WAS IMPLANTED ON (B)(6) 2008 AND EXPLANTED ON (B)(6) 2025. IT WAS FURTHER NOTED THAT THE REASON FOR REPLACEMENT WAS REPORTED AS A LEAFLET TEAR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cusp Tear

  MAUDE report 22066164 ↗
• InjuryMay 14, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT POST IMPLANT OF THIS 29MM FREESTYLE AORTIC 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 22019557 ↗
• InjuryJan 23, 2025Calcified; Patient Device Interaction Problem; Intravalvular regurgitation; Calcified; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN AORTIC BIOPROSTHETIC VALVE WAS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE RE PLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. IT WAS NOTED THAT PROTRUDING CALCIFICATION WAS SEEN IN THE SINOTUBULAR JUNCTION (STJ) AND A POSSIBLE DISSECTION WAS SEEN THROUGHOUT THE ASCENDING ARCH, AORTIC ARCH, AND DESCENDING THORACIC AORTA. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED ON THE SAME DAY FOR AN URGENT VALVE-IN-VALVE PROCEDURE DUE TO SEVERE AORTIC REGURGITATION. THE PROCEDURE WAS PERFORMED USING AN TRANSCATHETER AORTIC VALVE OF A DIFFERENT MANUFACTURER. THE PROCEDURE AND IMMEDIATE RECOVERY WERE UNREMARKABLE.

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

  MAUDE report 21214988 ↗
• InjuryJan 7, 2025Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 29MM AORTIC FREESTYLE VALVE IS EXPERIENCING SEVERE AORTIC INSUFFICIENCY. IT WAS STATED THAT THERE IS A POSSIBLE DISSECTION IN THE LEFT CORONARY CUSP (LCC). NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Vascular Dissection

  MAUDE report 21092169 ↗
• InjuryDec 9, 2024Intravalvular regurgitation; 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 REPORTED AS MODERATE TO SEVERE AORTIC INSUFFICIENCY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20878539 ↗
• MalfunctionNov 15, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 7 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 AORTIC STENOSIS (AS). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 20700385 ↗
• MalfunctionNov 13, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 12 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 REPORTED AS AORTIC REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20678181 ↗
• InjuryNov 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 17 YEARS AND 1 MONTH POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT (CVA). IT WAS STATED THAT NEUROLOGY DETERMINED THAT IT WAS DUE TO EITHER BEING OFF ANTICOAGULATION, A ARTERIAL CARDIAC CATHETERIZATION PERFORMED TWO DAYS PRIOR, OR CANCER -RELATED HYPERCOAGULABILITY. IT WAS REPORTED THAT NO TREATMENT WAS PROVIDED DUE TO THE PATIENT¿S DEFICITS RESOLVING RATHER RAPIDLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Stroke/CVA

  MAUDE report 20631047 ↗
• InjuryOct 31, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 9 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 20579730 ↗
• InjuryOct 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 11 YEARS AND 4 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT (CVA). IT WAS STATED THAT THE CAUSE OF THIS CVA IS UNKNOWN. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Stroke/CVA

  MAUDE report 20537737 ↗
• InjuryOct 25, 2024Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 16 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 REPORTED AS SEVERE AORTIC INSUFFICIENCY (AI), HYPERTENSION AND HEART FAILURE. IT WAS NOTED THAT THERE WAS A POSSIBLE DISSECTION IN AORTIC ROOT AND ASCENDING AORTA. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure; High Blood Pressure/ Hypertension

  MAUDE report 20535287 ↗
• InjuryOct 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 14 YEARS AND 4 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT (CVA). IT WAS STATED THAT THE CAUSE OF THIS CVA IS UNKNOWN. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Stroke/CVA

  MAUDE report 20535229 ↗