MOSAIC ULTRA® 305U23 (UDI 00885074253244)Recalls & reported problems

Summary

The FDA's MAUDE database contains 239 adverse event reports that list this exact device (DI 00885074253244), received between Jul 7, 2017 and Jan 16, 2026 — classified as 237 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (170 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 239 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT 16 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, HEMODYNAMICS INSTABILITY AND CONGESTIVE HEART FAILURE (CHF). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Failure/Congestive Heart Failure; Valvular Stenosis

  MAUDE report 24092337 ↗
• InjuryJan 13, 2026Calcified; Gradient Increase; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT 12 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 Insufficiency/ Regurgitation; Calcium Deposits/Calcification; Insufficient Information

  MAUDE report 24052138 ↗
• InjuryNov 11, 2025Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 9 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE AORTIC REGURGITATION. IT WAS ALSO REPORTED THAT A TRANSCATHETER VALVE-IN-VALVE INTERVENTION WAS ATTEMPTED 1 MONTH EARLIER BUT WAS ABORTED AS THE PATIENT HAD HEMODYNAMIC INSTABILITY. IT WAS FURTHER NOTED THAT THE PATIENT HAD SIGNIFICANT CORONARY ARTERY DISEASE (CAD), WHICH CONTRIBUTED TO THE HEMODYNAMIC INSTABILITY, AS WELL AS THE TRANSCATHETER VALVE'S IMPLANT DEPTH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23527542 ↗
• InjuryNov 11, 2025Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 7 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, APPROXIMATELY 1 MONTH LATER, A TRANSCATHETER VALVE WAS ATTEMPTED TO BE IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC REGURGITATION. IT WAS FURTHER NOTED THAT THE VALVE-IN-VALVE EVENT WAS ABORTED DURING THE PROCEDURE DUE TO HEMODYNAMIC INSTABILITY. IT WAS FURTHER NOTED THAT THE PATIENT HAD SIGNIFICANT CORONARY ARTERY DISEASE (CAD), WHICH CONTRIBUTED TO THE HEMODYNAMIC INSTABILITY, AS WELL AS THE TRANSCATHETER VALVE IMPLANT DEPTH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23527406 ↗
• InjuryOct 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 YEAR AND 5 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE IMPLANTED IN THE PULMONARY POSITION, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME(SSS). NO ADDITIONAL A DVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23401841 ↗
• InjuryOct 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 14 YEARS AND 3 MONTHS POST-IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, IMPLANTED IN THE PULMONARY POSITION, AN 18MM TRANSCATHETER PULMONARY 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 23347266 ↗
• InjuryAug 11, 2025Calcified; Insufficient Device Problem Information; Intravalvular regurgitation; Calcified; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS SEVERE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 22771981 ↗
• InjuryApr 22, 2025Calcified; Intravalvular regurgitation; Calcified; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 18 YEARS AND 1 MONTH 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 REPORTED THAT CALCIUM COULD BE SEEN IN THE SINOTUBULAR JUNCTION, IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND THE LEFT CORONARY ARTERY (LCA) AND UNDER THE LEFT CORONARY CUSP (LCC). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 1 DAY LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21885120 ↗
• InjuryApr 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS EXPLANTED AND REPLACED WITH AN NON-MEDTRONIC VALVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21773350 ↗
• InjuryJan 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS THIRD-DEGREE ATRIOVENTRICULAR (AV) BLOCK (COMPLETE HEART BLOCK). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 21264337 ↗
• InjuryJan 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS  REPORTED AS INCOMPLETE ATRIOVENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 21264329 ↗
• MalfunctionJan 23, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 14 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 REPORTED AS MILD AORTIC REGURGITATION AND AORTIC STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21218713 ↗
• InjuryJan 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 11 MONTHS 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 21218019 ↗
• InjuryJan 17, 2025Calcified; Gradient Increase; Incomplete Coaptation; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Calcified; Gradient Increase; Incomplete Coaptation; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 13 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 INSUFFICIENCY OF UNKNOWN SEVERITY. IT WAS ALSO REPORTED THAT THE PATIENT WAS BECOMING MORE SYMPTOMATIC. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 5 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21184480 ↗
• MalfunctionJan 15, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION 12 YEARS AND 11 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE THAT 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 21161736 ↗
• InjuryJan 13, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT AN AORTIC TISSUE VALVE WAS INITIALLY IMPLANTED ON (B)(6) 2009. SUBSEQUENTLY, A NEW TRANSCATHETER AORTIC VALVE REPLACEMENT WAS PERFORMED ON (B)(6) 2023. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 21136303 ↗
• InjuryJan 7, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 23MM MOSAIC AORTIC ULTRA VALVE HAS AORTIC REGURGITATION. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO INTERVENTION OR ADVERSE HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21091131 ↗
• InjuryJan 6, 2025Calcified; Device Stenosis; Intravalvular regurgitation; Calcified; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 11 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 NOT REPORTED. IT WAS MENTIONED THAT THERE WAS CALCIFICATION OBSERVED IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) UNDER THE NON-CORONARY CUSP (NCC). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED SUBSEQUENTLY, 8 DAYS LATER, ANOTHER MANUFACTURERS TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS AND MODERATE TO SEVERE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21077629 ↗
• InjuryDec 2, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE REASON FOR INTERVENTION WAS DUE TO SEVERE REGURGITATION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 20818957 ↗
• InjuryNov 28, 2024Calcified; Intravalvular regurgitation; Calcified; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THAT 2 MONTHS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20804885 ↗
• InjuryNov 27, 2024Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT HIGH GRADIENTS WERE IDENTIFIED WITH A MEDTRONIC VALVE (VALVE MOSAIC AORTIC ULTRA 23MM). THE ISSUE LED TO THE REPLACEMENT OF THE MEDTRONIC VALVE WITH ANOTHER TRANSCATHETER VALVE, WHICH WAS ALSO IMPLANTED VALVE-IN-VALVE. THERE WERE NO PATIENT SYMPTOMS OR ADVERSE OUTCOMES REPORTED AS A RESULT OF THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20795307 ↗
• InjuryOct 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR POST IMPLANT OF THIS 23MM 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 20535743 ↗
• InjuryOct 8, 2024Calcified; Patient Device Interaction Problem; Intravalvular regurgitation; Calcified; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 17 YEARS AND 3 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVAL UATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC INSUFFICIENCY (AI) AND HEART FAILURE. IT WAS ALSO STATED THAT CALCIFICATION WAS OBSERVED IN THE SINOTUBULAR JUNCTION (STJ). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 8 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Calcium Deposits/Calcification; Heart Failure/Congestive Heart Failure

  MAUDE report 20396189 ↗
• InjuryOct 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 4 MONTHS POST IMPLANT OF THIS 23MM 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 20362183 ↗
• InjurySep 6, 2024Gradient Increase; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Device Stenosis; Gradient Increase; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 11 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVA LUATED 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 20163199 ↗

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