Avalus UltraRecalls & reported problems across all models

We found 6 models of Avalus Ultra by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Sep 4, 2024 and Sep 17, 2026 — classified as 2 deaths, 57 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (30 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Avalus Ultra problems

Avalus Ultra models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Avalus Ultra™ 400U25

  heart-valve, non-allograft tissue
  23 reports
• Avalus Ultra™ 400U27

  heart-valve, non-allograft tissue
  22 reports
• Avalus Ultra™ 400U23

  heart-valve, non-allograft tissue
  2 deaths14 reports
• Avalus Ultra™ 400U21

  heart-valve, non-allograft tissue
  4 reports
• Avalus Ultra™ 400U29

  heart-valve, non-allograft tissue
  3 reports
• Avalus Ultra™ 400U19

  heart-valve, non-allograft tissue
  2 reports

Recent Avalus Ultra adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Insufficient Device Problem Information

  Medtronic received information that 1 year post implant of this 27mm aortic bioprosthetic valve, it was explanted and replaced with an unknown device. The reason for the replacement was not reported. No additional adverse patient effects were reported.

  Patient problems: Insufficient Information

  MAUDE report 50798994 ↗
• InjuryJun 30, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS AND 2 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM AORTIC BIOPROSTHETIC 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 25666049 ↗
• InjuryJun 3, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 23MM BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC DEVICE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS PATIENT ANATOMY. IT WAS REPORTED THAT THE SURGEON OVERSIZED THE VALVE AND THE PRODUCT DID NOT MALFUNCTION. IT WAS STATED THAT BOTH THE BARREL END AND REPLICA END OF THE AVALUS SIZERS AND A BODY SURFACE AREA (BSA) CHART WERE USED FOR VALVE SIZING. THE BSA CHART DID NOT INDICATE A LARGER VALVE WAS NEEDED THAN WHAT WAS SIZED FOR THIS PATIENT AND THE ANNULUS WAS NOT FELT TO BE BETWEEN TWO DIFFERENT VALVE SIZES. IT WAS REPORTED THAT PLEDGETS WERE USED AND THE VALVE WAS RE-SIZED FOLLOWING THE PLEDGET PLACEMENT. IT WAS STATED THAT THE SURGEON WAS NEW WITH THE AVALUS VALVE AND SIZERS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25375984 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 11 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NEW 25MM A ORTIC 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 24752725 ↗
• InjuryMar 13, 2026Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT HAD ENDOCARDITIS. THE ORGANISM CULTURED WAS ESCHERICHIA COLI (E.COLI). MEDICATION WAS ADMINISTERED. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis

  MAUDE report 24590423 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED V ALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24529885 ↗
• InjuryMar 5, 2026Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AND 6 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM AORTIC BIOPROSTHETIC 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; Endocarditis; Insufficient Information

  MAUDE report 24520348 ↗
• InjuryMar 4, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 21MM AORTIC BI OPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE 23MM AORTIC BIOPROSTHETIC VALVE WAS TOO BIG AND A 21MM AORTIC BIOPROSTHETIC VALVE WAS SELECTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24504944 ↗
• DeathFeb 19, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT REPORTED THE PATIENT PRESENTED TO THE FACILITY IN SALVAGE CRITICAL CONDITION, AS THEY HAD SEVERE AORTIC VALVE ENDOCARDITIS. A POSITIVE BLOOD CULTURE WAS CONFIRMED FOR THE SAME ORGANISM FOUND IN A URINE CULTURE WEEKS PRIOR. IT WAS ALSO REPORTED THAT A VEGETATION COULD BE SEEN ON THE PATIENTS NATIVE RIGHT AND NON-CORONARY CUSP. THE PATIENT ALSO HAD SYMPTOMS OF SHORTNESS OF BREATH. RE-INSPECTION OF THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) REVEALED ADDITIONAL ABSCESS AND TISSUE DESTRUCTION, REQUIRING FURTHER DEBRIDEMENT AND PATCH RECONSTRUCTION. THE 23MM AORTIC BIOPROSTHETIC VALVE WAS IMPLANTED AFTER DEBRIDEMENT WAS COMPLETED. IT WAS FURTHER NOTED THAT SUBSEQUENTLY, 1 DAY LATER, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE VALVE COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 24394442 ↗
• DeathJan 28, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE CAUSE OF DEATH AS UNKNOWN. IT WAS FURTHER NOTED THAT THE PATIENT DEATH WAS DETERMINED AS NOT RELATED TO THE DEVICE, BUT WAS RELATED TO THE IMPLANT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hypoxia; Insufficient Information

  MAUDE report 24197969 ↗
• InjuryJan 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 13 DAYS POST IMPLANT OF THIS 27MM 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: Atrial Fibrillation; Atrial Flutter; Bradycardia; Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 24187130 ↗
• InjuryJan 26, 2026Incomplete Coaptation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURERS PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS AFTER IMPLANT, A CENTRAL JET CAUSING AORTIC INSUFFICIENCY WAS IDENTIFIED WITH POOR COAPTATION. IT WAS FURTHER NOTED THAT ADDITIONAL SUTURES WERE ADDED, HOWEVER THE CENTRAL JET AND AORTIC INSUFFICIENCY CONTINUED, THEREFORE THE VALVE WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180283 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN MEDTRONIC VALVE PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS DURING IMPLANT, THE VALVE SUTURES LOOKED TO BE MISPLACED, OR POSSIBLY GOING INTO THE LEAFLETS. IT WAS FURTHER NOTED THAT THE VALVE AREA WHERE THE LEAFLETS MEET THE CUFF WAS CRIMPED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24069313 ↗
• InjuryJan 7, 2026Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT HAD THROMBOCYTOPENIA. IT WAS FURTHER REPORTED THAT THE PATIENTS PLATELETS CONTINUED TO DROP AFTER THE IMPLANT PROCEDURE, DROPPING TO 29X10^E3/UL. THE PATIENT WAS GIVEN TREATMENT WITH THERAPEUTIC PLASMA EXCHANGE (TPE) AND RECEIVED 13 UNITS OF PACKED RED BLOOD CELLS (PRBC). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23992996 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE 23MM AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED AND REPLACED WITH A 23MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD SEVERE AORTIC VALVE ENDOCARDITIS, AS THEY HAD A POSITIVE BLOOD CULTURE FOR THE SAME ORGANISM FOUND IN A URINE CULTURE WEEKS PRIOR. IT WAS ALSO REPORTED THAT A VEGETATION COULD BE SEEN ON THE PATIENTS NATIVE RIGHT AND NON-CORONARY CUSP. THE PATIENT ALSO HAD SYMPTOMS OF SHORTNESS OF BREATH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23973109 ↗

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