MOSAIC ULTRA® 305U25Recalls & reported problems

Summary

The FDA's MAUDE database contains 234 adverse event reports that list this exact device (DI 00885074253251), received between Jul 24, 2017 and Sep 23, 2026 — classified as 1 death, 231 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (163 reports).

3 other recalls cover devices cleared under the same FDA submission (P990064); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 234 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Patient Device Interaction Problem

  Medtronic received information that 6 days post implant of this 25mm Mosaic heart valve, a permanent pacemaker was implanted. The reason for the permanent pacemaker was not reported. No additional adverse patient effects were reported.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 50866038 ↗
• InjuryApr 13, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT 13 YEARS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A NON-MEDTRONIC 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 24856901 ↗
• InjuryFeb 19, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 MONTH POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Tachycardia

  MAUDE report 24388186 ↗
• InjuryFeb 4, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 6 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A BI-VENTRICULAR DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE BI-VENTRICULAR DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY, LOW EJECTION FRACTION AND ATRIAL ARRYTHMIAS (ATRIAL T ACHYCARDIA (AT), ATRIAL FIBRILLATION (AF), AND ATRIAL FLUTTER (A-FL)). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Cardiomyopathy; Tachycardia

  MAUDE report 24256862 ↗
• InjuryJan 14, 2026Calcified; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT 16 YEARS AND 8 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED PER ECHOCARDIOGRAM AS MODERATE TO SEVERE AORTICREGURGITATION. IT WAS REPORTED THAT PATIENT ALSO SUFFERED DECOMPENSATED HEART FAILURE, SHORTNESS OF BREATH ON EXERTION (SOB), FATIGUE AND LOWER EXTREMITY EDEMA. EVIDENCE OF CALCIFICATION WAS SEEN ON THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) UNDER THE NON-CORONARY CUSP (NCC) AND IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA), SINO-TUBULAR JUNCTION (STJ) AND ASCENDING AORTA. SUBSEQUENTLY ON (B)(6) 2025 THE PATIENT SUCCESSFULLY HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A NON-MEDTRONIC TRANSCATHETER VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Calcium Deposits/Calcification; Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure; Swelling/ Edema

  MAUDE report 24067825 ↗
• InjuryAug 28, 2025Gradient Increase; Thickening of Material; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Thickening of Material; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 4 MONTHS POST IMPLANT OF THIS MOSAIC AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. IT WAS REPORTED THAT SIGNIFICANT STRUCTURAL VALVE DETERIORATION WAS NOTED WITH THICKENING OF THE LEAFLETS AND PROLAPSE OF THE LEFT CORONARY CUSP. IT WAS STATED THAT THE PEAK VELOCITY ACROSS THE VALVE WAS 4.2 M/S, MEAN PRESSURE GRADIENT WAS 46 MMHG AND AORTIC VALVE AREA WAS 0.9 CM². IT WAS REPORTED THAT MODERATE ECCENTRIC AORTIC REGURGITATION WAS PRESENT DUE TO THE LEAFLET PROLAPSE. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 22917424 ↗
• InjuryAug 26, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 4 MONTHS POST IMPLANT OF THIS MOSAIC AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS (AS) AND AN ELEVATED GRADIENT OF 48MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22893346 ↗
• InjuryMay 29, 2025Calcified; Device Stenosis; Intravalvular regurgitation; Calcified; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE SEVERITY OF AORTIC STENOSIS AND AORTIC INSUFFICIENCY AS SEVERE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 22108635 ↗
• InjuryMay 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 16 YEARS AND 6 MONTHS POST IMPLANT OF THIS MOSAIC AORTIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS EJECTION FRACTION (EF) AND DYSSYNCHRONY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22070626 ↗
• InjuryMay 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS MOSAIC 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 22052974 ↗
• InjuryMay 6, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS REPORTED THAT 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 STATED THAT CALCIUM WAS SEEN IN THE PROXIMAL LEFT CORONARY ARTERY (LCA). NO INTERVENTION OR PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Calcium Deposits/Calcification; Insufficient Information

  MAUDE report 21969154 ↗
• InjuryFeb 12, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR INTERVENTION WAS DUE TO STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 21364183 ↗
• InjuryDec 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 10 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS 3RD DEGREE ATRIOVENTRICULAR BLOCK OR COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 20875548 ↗
• MalfunctionDec 3, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 6 MONTHS POST IMPLANT OF THIS 25MM 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 STATED THAT THE VALVE HAD DEGENERATIVE CHANGES OCCUR TO ALL LEAFLETS WITH IT BEING NOTED THAT THE NON CORONARY CUSP LEAFLET RECENTLY BECOMING COMPLETELY FLAILED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20834202 ↗
• InjuryNov 26, 2024Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH SEVERE SYMPTOMATIC NON-RHEUMATIC PARADOXICAL LOW-FLOW, LOW-GRADIENT AORTIC STENOSIS IN A BOVINE BIOPROSTHETIC SURGICAL AORTIC VALVE REPLACEMENT (SAVR) FROM 2010 WAS UNDERGOING A WORKUP FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT-IN-SAVR. NO TREATMENT OR INTERVENTION WAS PROVIDED OR PLANNED FOR THE CURRENT SYMPTOMS, AND IT WAS UNKNOWN IF THE MEDTRONIC DEVICE CONTRIBUTED TO THE SYMPTOMS. THE PATIENT WAS ALIVE WITH NO REPORTED INJURY. SUBSEQUENTLY, 7 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 20784709 ↗
• InjuryNov 25, 2024Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION WHICH STATED THAT ANOTHER REASON FOR INTERVENTION WAS SEVERE CENTRAL AORTIC REGURGITATION (AR). IT WAS STATED THAT THAT THE PATIENT HAD HEART FAILURE SYMPTOMS WHICH REQUIRED DIURETICS PRIOR TO TRANSCATHETER VALVE-IN-VALVE REPLACEMENT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 20772919 ↗
• InjuryNov 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 20758397 ↗
• InjuryNov 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 2 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM 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 20596922 ↗
• MalfunctionAug 15, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT 16 YEARS AND 5 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 19996096 ↗
• InjuryJul 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 11 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: Insufficient Information

  MAUDE report 19674578 ↗
• InjuryJun 28, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS MODERATE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19635442 ↗
• InjuryJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 9 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: Insufficient Information

  MAUDE report 19633621 ↗
• InjuryJun 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 4 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 19614734 ↗
• InjuryJun 24, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR REPLACEMENT WAS REPORTED AS AORTIC STENOSIS (AS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 19599852 ↗
• InjuryJun 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 6 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: Insufficient Information

  MAUDE report 19582732 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990064. One submission often covers many models, so check the product and lot details in each record.

• Z-1881-2019 · May 21, 2019 · Terminated
  Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
• Z-1880-2019 · May 21, 2019 · Terminated
  Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
• Z-1225-2009 · Jan 26, 2009 · Terminated
  Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart Valve; Model 305; Catalog #s 305C21AA, 305C2701, 305C2301, 305C2501, and 305C2901; Sterile LC; Rx only; Medtronic Inc 710 M