Avalus Ultra™ 400U25Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00763000647056), received between Nov 27, 2024 and Jun 30, 2026 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (11 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• 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 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 ↗
• InjuryNov 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT EXPERIENCED MEDIASTINAL HEMORRHAGE P OST-PROCEDURE. POST-OPERATIVELY, THE PATIENT HAD HIGH CHEST TUBE OUTPUT WITH SIGNIFICANT COAGULOPATHY AND DEVELOPED A HEMATOMA THAT REQUIRED EVACUATION. THE PATIENT UNDERWENT MEDIASTINAL WASHOUT WITH EVACUATION OF THE HEMATOMA AND RECEIVED A TRANSFUSION OF FOUR UNITS OF PACKED RED BLOOD CELLS. THESE EVENTS RESULTED IN A PROLONGATION OF THE EXISTING HOSPITALIZATION. IT WAS REPORTED THAT THE PATIENT RECOVERED AND THE ADVERSE EVENT RESOLVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23657461 ↗
• InjuryNov 18, 2025Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS REPLACED WITH A VALVE OF THE SAME SIZE AND MODEL. IT WAS REPORTED THAT THE VALVE WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23581923 ↗
• MalfunctionNov 11, 2025Unsealed Device Packaging; Device Markings/Labelling Problem; Packaging Problem; Unsealed Device Packaging; Device Markings/Labelling Problem; Packaging Problem

  IT WAS REPORTED THAT AN AVALUS VALVE WAS FOUND TO HAVE A PACKAGING ISSUE, WITH THE PACKAGING COMPROMISED AND THE GLASS JAR COMPLETELY BROKEN. THE DEVICE WAS INSPECTED BEFORE USE AND WAS NEVER IMPLANTED OR USED ON A PATIENT. THE ISSUE WAS IDENTIFIED DURING EVALUATION OF THE VALVES BEFORE THE CASE STARTED, AND IT WAS SUSPECTED THAT THE DAMAGE OCCURRED DURING DELIVERY. A REPLACEMENT WAS PROVIDED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522745 ↗
• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM VALVE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS DUE TO THE LEFT CORONARY OSTIA BEING CLOSED OFF WITH THE COR-KNOT SUTURE DEVICE. IT WAS FURTHER REPORTED THAT THE VALVE WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23303165 ↗
• InjurySep 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 WEEKS POST IMPLANT OF THIS 25MM AVALUS VALVE, IT WAS EXPLANTED AND REPLACED WITH A DEVICE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23061790 ↗
• InjuryAug 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 25MM AVALUS VALVE, THE PATIENT DEVELOPED ACUTE PULMONARY INSUFFICIENCY WHICH PROLONGED HOSPILIZATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea

  MAUDE report 22883590 ↗
• InjuryAug 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST IMPLANT OF THIS 25MM AVALUS VALVE, THE PATIENT EXPERIENCED AN EPISODE OF ATRIAL FLUTTER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Flutter

  MAUDE report 22883380 ↗
• InjuryAug 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 25MM AVALUS VALVE, THE PATIENT EXPERIENCED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 22873959 ↗
• InjuryAug 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 25MM AVALUS VALVE, THE PATIENT EXPERIENCED ACUTE KIDNEY INJURY CHARACTERIZED BY ANURIA, A WEIGHT INCREASE FROM A BASELINE OF 125 LBS TO 147 LBS, AND ELEVATED CREATININE LEVELS FROM A BASELINE OF 0.8 MG/DL TO 2.48 MG/DL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Kidney injury

  MAUDE report 22873751 ↗
• InjuryAug 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE PATIENT RECEIVED 10 UNITS OF PACKED RED BLOOD CELLS (PRBC) THROUGH TRANSFUSION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22854756 ↗
• InjuryJun 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT HAD ATRIAL FIBRILLATION. MEDICATION WAS GIVEN INCLUDING HEPARIN AND AMIODARONE. THE PATIENT REMAINED IN RAPID ATRIAL FIBRILLATION. CARDIOVERSION WAS THEN PERFORMED, AND THE PATIENT CONVERTED TO NON-SINUS RHYTHM. HOSPITALIZATION WAS PROLONGED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 22234891 ↗
• InjuryJun 17, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT FOUR 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 Stenosis; Insufficient Information

  MAUDE report 22234867 ↗
• InjuryMay 5, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THERE WAS A LARGE LEFT PNEUMOTHORAX WHICH WAS DISCOVERED ON X-RAY. ADDITIONAL INTERVENTION WAS NECESSARY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 21959754 ↗
• InjuryFeb 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21305439 ↗
• InjuryFeb 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE PHYSICIAN DOES NOT BELIEVE THAT THE HEART VALVE OR IMPLANT PROCEDURE CAUSED OR CONTRIBUTED TO THE CONDUCTION DISTURBANCE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 21300486 ↗
• InjuryJan 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 MONTHS AND 1 DAY POST IMPLANT OF THIS 25MM 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 21274003 ↗
• InjuryJan 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT A COMPUTED TOMOGRAPHY (CT) DISCOVERED MILD SMALL VESSEL ISCHEMIC DISEASE, AND A MAGNETIC RESONANCE IMAGING (MRI) DISCOVERED AN ACUTE INFARCTION OF THE LEFT HEMIPONS WITH NO ACUTE HEMORRHAGE, INDICATIVE OF A STROKE. IT WAS ALSO REPORTED THAT THE PATIENT HAD GLOBAL WEAKNESS AND CLUMSINESS DESCRIBED AS DIFFICULTY MOVING EXTREMITIES AND HANDS. THE LEFT HEMIBODY CONTINUED TO IMPROVE, HOWEVER THE RIGHT SIDED DEFICITS PERSISTED. A STROKE CODE WAS INITIATED, AND ON EXAM THE PATIENT HAD RIGHT SIDED HEMIBODY WEAKNESS PROXIMALLY, WITH MILD DYSARTHRIA AND MILD DYSMETRIA/CLUMSINESS. STROKE IMAGINING WAS CONDUCTED, AND SHOWED NO EVIDENCE OF HEMORRHAGE, MASS EFFECT OR EVIDENCE SUGGESTIVE OF ISCHEMIC STROKE WITH NO PERFUSION DEFICIT. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DISCOVERED NO EVIDENCE OF LARGE VESSEL OCCLUSION OR FLOW LIMITING STENOSIS. NO INTERVENTION WAS REPORTED. THE PATIENT HOSPITALIZATION WAS PROLONGED DUE TO THIS EVENT. SUBSEQUENTLY, 7 DAYS LATER, THE PATIENT WAS DISCHARGED AND RECOVERED/RESOLVED. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE DEVICE AND THE PROC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 21085566 ↗
• InjuryNov 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A VALVE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20796834 ↗