MOSAIC ULTRA® 305U223 (UDI 00643169001664)Recalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 00643169001664), received between Jan 23, 2017 and Aug 31, 2026 — classified as 3 deaths, 151 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (101 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 163 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Calcified; Device Stenosis; Intravalvular regurgitation

  Additional Information received reported that an intervention was planned for (b)(6)2026. Evidence of calcification was seen in the the left ventricular outflow tract (LVOT) under right coronary cusp (RCC), left coronary cusp (LCC), and non coronary cusp (NCC). No additional adverse patient effects were reported.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Calcium Deposits/Calcification; Syncope/Fainting

  MAUDE report 50517390 ↗
• InjuryAug 23, 2026Intravalvular regurgitation

  It was reported that 7 years and 6 months post implant of this 23mm 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. It was reported that an intervention is required. No additional adverse patient effects were reported.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50397419 ↗
• InjuryAug 4, 2026Intravalvular regurgitation

  It was reported that 11 years and 2 months post implant of this 23mm 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 central regurgitation. It was reported that an intervention was required and subsequently on the same day, the patient successfully had a 23mm aortic transcatheter valve-in-valve replacement. No additional adverse patient effects were reported.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50135352 ↗
• InjuryJun 4, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 9 YEARS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A 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 25390935 ↗
• MalfunctionMay 29, 2026Device Stenosis

  IT WAS REPORTED THAT 12 YEARS AND 10 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25328625 ↗
• InjuryApr 14, 2026Device Stenosis

  IT WAS REPORTED THAT 12 YEARS AND 7 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS VALVE STENOSIS. IT WAS REPORTED THAT AN INTERVENTION IS SCHEDULED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24869473 ↗
• InjuryMar 20, 2026Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REASON FOR EVALUATION WAS STENOSIS, TRACE INTERVALVULAR REGURGITATION, HEART FAILURE AND SHORTNESS OF BREATH. EVIDENCE OF CALCIFICATION WAS SEEN UNDER NON CORONARY CUSP (NCC), LEFT VENTRICULAR OUTFLOW TRACT (LVOT) AND IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). SUBSEQUENTLY ON (B)(6) 2026, THE PATIENT SUCCESSFULLY HAD A 23MM AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Calcium Deposits/Calcification; Dyspnea; Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 24647526 ↗
• InjuryMar 18, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT 9 YEARS AND 11 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC 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: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 24632272 ↗
• InjuryMar 17, 2026Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT 14 YEARS AND 3 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS VALVE STENOSIS, HEART FAILURE, CONGESTIVE HEART FAILURE (CHF) AND HEMODYNAMIC INSTABILITY. SUBSEQUENTLY, THE PATIENT SUCCESSFULLY HAD A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure

  MAUDE report 24617411 ↗
• InjuryMar 4, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT 14 YEARS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC 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: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 24506579 ↗
• MalfunctionFeb 20, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 11 YEARS AND 7 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVES, 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 24400048 ↗
• InjuryJan 21, 2026Calcified; Perivalvular Leak; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON (B)(6) 2026, THE PATIENT SUCCESSFULLY HAD AN AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Calcium Deposits/Calcification; Mitral Valve Insufficiency/ Regurgitation; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 24132211 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 11 YEARS AND 2 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NEW 23MM 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 23836436 ↗
• InjuryDec 17, 2025Gradient Increase; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS SEVERE AORTIC REGURGITATION, MODERATE AORTIC STENOSIS, PATIENT PROTHESIS MISMATCH, AN EJECTION FRACTION OF 30% AND A MEAN GRADIENT OF 37MMHG. IT WAS FURTHER REPORTED THAT A AORTIC ROOT AND ASCENDING AORTA REPLACMENT HAD OCCURRED CONCOMITANTLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23826256 ↗
• InjuryNov 4, 2025Patient Device Interaction Problem; Device Stenosis; Patient Device Interaction Problem; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 8 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 STENOSIS. AN INTERVENTION IS REQUIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 20 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS FURTHER REPORTED AS A LOW EJECTION FRACTION OF 30-40%. IT WAS FURTHER NOTED THAT THE PATIENT HAD SYMPTOMS OF WEAKNESS AND FATIGUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Fatigue; Muscle Weakness/Atrophy

  MAUDE report 23466939 ↗
• InjuryOct 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 10 YEARS AND 9 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A 23MM 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 23434915 ↗
• InjuryOct 30, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC 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: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 23423091 ↗
• InjuryOct 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED REPORTED THAT ON (B)(6) 2025 A 23MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 23411351 ↗
• InjuryOct 24, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT 13 YEARS AND 2 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS MODERATE AORTIC CENTRAL REGURGITATION. SUBSEQUENTLY IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23380455 ↗
• InjurySep 15, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT 14 YEARS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A 23MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-I N-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE CENTRAL AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23050597 ↗
• InjuryAug 28, 2025Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 2 MONTHS POST IMPLANT OF THIS 23MM MOSAIC 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; Aortic Valve Stenosis; Insufficient Information

  MAUDE report 22913838 ↗
• InjuryJul 15, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 7 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 STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22511482 ↗
• InjuryJul 8, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS POST IMPLANT OF THIS MOSAIC AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22438193 ↗
• InjuryJun 3, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 5 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 STENOSIS. AN INTERVENTION IS SCHEDULED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 1 WEEK LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS ALSO REPORTED AS AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 22135466 ↗
• DeathMay 22, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 6 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, THE RELATEDNESS OF THE DEATH TO THE AORTIC BIOPROSTHETIC VALVE CAN NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Cardiogenic Shock; Chills; Fever; Insufficient Information; Low Blood Pressure/ Hypotension; Sepsis

  MAUDE report 22073464 ↗

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-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-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-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