FREESTYLE® FR995-21 (UDI 00643169002111)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00643169002111), received between Mar 22, 2018 and Mar 20, 2026 — classified as 2 deaths, 25 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (19 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 DAYS POST IMPLANT OF THIS 21MM 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 24647619 ↗
• InjuryNov 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 6 YEARS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 23654446 ↗
• MalfunctionNov 7, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT 10 YEARS AND 11 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO INTERVENTION OR ADDITIONAL PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification; Insufficient Information

  MAUDE report 23497868 ↗
• InjuryOct 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 21MM 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 23360475 ↗
• InjuryAug 28, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS REPORTED THAT ON (B)(6) 2025, THE VALVE WAS EXPLANTED AND REPLACED WITH A 21MM AORTIC BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22918927 ↗
• MalfunctionAug 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 2 MONTHS POST IMPLANT OF THIS 21MM FREESTYLE AORTIC 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 22894398 ↗
• InjuryMar 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 21MM FREESTYLE AORTIC VALVE, IT WAS IMMEDIATELY EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21517256 ↗
• InjuryAug 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 11 MONTHS POST IMPLANT OF THIS 21MM 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 20030516 ↗
• InjuryJun 19, 2024Gradient Increase; Insufficient Device Problem Information; Device Stenosis; Gradient Increase; Insufficient Device Problem Information; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 7 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE IMPLANTED IN THE PULMONARY POSITION, A 18MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Pulmonary Valve Stenosis

  MAUDE report 19566126 ↗
• InjuryApr 24, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 5 MONTHS POST IMPLANT OF THIS 21MM 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 (AR) . NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19175051 ↗
• InjuryFeb 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 10 DAYS POST IMPLANT OF THIS 21MM 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 18650868 ↗
• InjuryJun 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION 8 YEARS AND 7 MONTHS POST IMPLANT OF THIS 21MM 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 ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17069654 ↗
• InjuryMay 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 5 MONTHS POST IMPLANT OF THIS 21MM 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 14520679 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS NOT REPORTED. IT WAS ALSO REPORTED THAT IN AN UNKNOWN DURATION POST IMPLANT, THE PATIENT HAD STROKE AND THE CAUSE OF THE STROKE WAS NOT REPORTED. HOWEVER, IT WAS REPORTED THAT THROMBUS WAS PRESENT AND THE PATIENT WAS IN COMPLIANCE WITH ANTICOAGULATION THERAPY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 13943894 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 21 MM AORTIC BIOPROSTHETIC VALVE IMPLANTED IN THE PULMONARY POSITION, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIOVENTRICULAR BLOCK (3RD DEGREE COMPLETE HEART BLOCK). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 10854242 ↗
• InjuryNov 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 MONTHS AND 20 DAYS POST IMPLANT OF THIS 21MM BIOPROSTHETIC AORTIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10835689 ↗
• DeathMay 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT'S FAMILY MEMBER THAT THE PATIENT DIED "SHORTLY AFTER" THE IMPLANT OF THIS BIOPROSTHETIC AORTIC VALVE. PER THE OBITUARY, THE DATE OF DEATH WAS THE DATE OF THE SURGERY. THE CAUSE OF DEATH WAS NOT RECEIVED. THERE WAS NO EVIDENCE TO SUGGEST THAT THE AORTIC BIOPROSTHETIC VALVE OR ITS FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Death

  MAUDE report 10025158 ↗
• InjuryApr 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 4 MONTHS POST IMPLANT OF THIS 21MM AORTIC ROOT BIOPROSTHESIS, IT WAS EXPLANTED AND REPLACED WITH A 23MM AORTIC BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10005971 ↗
• InjuryMar 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF THIS 21MM BIOPROSTHETIC AORTIC ROOT REPLACEMENT, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT. THE REASON FOR THE PERMANENT PACEMAKER IMPLANT WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 9863358 ↗
• InjuryFeb 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 21MM BIOPROSTHETIC AORTIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9665030 ↗
• InjuryJan 27, 2020Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 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 Insufficiency; No Information

  MAUDE report 9632463 ↗
• InjuryAug 12, 2019Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 21MM BIOPROSTHETIC AORTIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 19MM BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8883815 ↗
• DeathAug 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT NINE MONTHS POST IMPLANT OF THIS 25 MM BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 21 MM VALVE OF THE SAME MODEL. THE REASON FOR THE EXPLANT WAS NOT REPORTED. IT WAS REPORTED THAT THE PATIENT DIED IN THE OPERATING ROOM. THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Aortic Dissection; Death

  MAUDE report 8869054 ↗
• InjuryJun 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT'S SPOUSE THAT 17 DAYS POST IMPLANT OF THIS 21MM BIOPROSTHETIC AORTIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM NON-MEDTRONIC VALVE.  THE REASONS FOR THE EXPLANT WERE REPORTED AS MODERATE TO SEVERE AORTIC STENOSIS AND SYMPTOMATIC CALCIFICATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 8697502 ↗
• InjuryApr 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 MONTHS AND 25 DAYS POST IMPLANT OF THIS 21MM AORTIC ROOT VALVE, IT WAS EXPLANTED AND REPLACED WITH A 21MM AORTIC ROOT VALVE OF AN UNKNOWN MANUFACTURER. THE REASON FOR REPLACEMENT WAS NOT REPORTED. IT WAS REPORTED THAT FIVE DAYS POST REPLACEMENT OF THE VALVE, THE PATIENT DIED DUE TO MULTI-SYSTEM ORGAN FAILURE. THERE WAS NO EVIDENCE TO SUGGEST THAT A MEDTRONIC VALVE OR ITS FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: No Information

  MAUDE report 8498305 ↗