MOSAIC® 310C29 (UDI 00885074247816)Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00885074247816), received between Nov 20, 2017 and Feb 25, 2026 — classified as 46 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (37 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 3 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A BIVENTRICULAR DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE BIVENTRICULAR DEFIBRILLATOR WAS REPORTED AS CONGESTIVE HEART FAILURE (CHF), CARDIOMYOPATHY AND NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASSIFICATION CLASS III. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy; Heart Failure/Congestive Heart Failure

  MAUDE report 24443629 ↗
• InjuryFeb 19, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 10 YEARS AND 2 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY AND LOW EJECTION FRACTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy; Non specific EKG/ECG Changes

  MAUDE report 24388293 ↗
• InjuryFeb 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 7 DAYS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PACEMAKER WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block; Non specific EKG/ECG Changes

  MAUDE report 24266975 ↗
• InjuryJan 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS MOSAIC MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MOSAIC MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21168409 ↗
• InjuryOct 15, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

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

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20451885 ↗
• InjuryOct 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 7 MONTHS POST IMPLANT OF THIS 29 MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29 MM 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 20398570 ↗
• InjuryMay 15, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED ADDITIONAL REASONS FOR REPLACEMENT AS SEVERE MITRAL REGURGITATION WITH PARTIAL FLAIL LEAFLET. THE SEVERITY OF MITRAL STENOSIS WAS ALSO REPORTED AS SEVERE. SUBSEQUENTLY, 4 WEEKS LATER, A MITRAL TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19321724 ↗
• InjuryNov 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 1 MONTH POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18214906 ↗
• InjurySep 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 11 MONTHS POST IMPLANT OF THIS 29MM MITRAL 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 17826981 ↗
• InjurySep 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS THAT THE REASON FOR THE REPLACEMENT WAS REPORTED AS TRICUSPID VALVE STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Tricuspid Valve Stenosis

  MAUDE report 17744436 ↗
• InjuryAug 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 10 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM 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 17584623 ↗
• InjuryJun 30, 2023Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 6 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM VALVE OF THE SAME MAKE AND MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE MITRAL STENOSIS AND MODERATE MITRAL REGURGITATION. IT WAS STATED THAT THERE WAS SEVERE CALCIFICATION OF ALL THREE LEAFLETS AND RETRACTION OF THE INFERIOR LEAFLET. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 17237888 ↗
• InjuryApr 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH REPORTED THAT THE 29MM MITRAL BIOPROSTHETIC VALVE HAD BEEN IMPLANTED IN THE MITRAL POSITION AND THAT 12 YEARS AND 11 MONTHS POST IMPLANT OF THIS VALVE, A 26MM NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. IT WAS STATED THAT THE REASON FOR REPLACEMENT WAS MODERATE TO SEVERE BIOPROSTHETIC MITRAL REGURGITATION AND DEVELOPMENT OF HEART FAILURE SYMPTOMS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16808914 ↗
• InjuryApr 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 5 MONTHS POST IMPLANT OF THIS 29MM MITRAL 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; Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis

  MAUDE report 16793934 ↗
• InjuryDec 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 6 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16014553 ↗
• InjuryNov 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 6 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNSPECIFIED MEDTRONIC MITRAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15749733 ↗
• InjuryApr 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 7 MONTHS POST IMPLANT OF THIS 29MM BIOPROSTHETIC MITRAL VALVE, A NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 11735642 ↗
• InjuryApr 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 8 MONTHS POST IMPLANT OF THIS 29MM MITRAL 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: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Endocarditis; Insufficient Information; Stroke/CVA

  MAUDE report 11651731 ↗
• InjuryMar 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 10 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31 MM 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 11561757 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 29MM MITRAL 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 11452618 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC 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 11445159 ↗
• InjuryMar 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 10 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A VALVE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MITRAL STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 11402652 ↗
• InjuryFeb 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 11 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC MITRAL 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 11312962 ↗
• InjuryJan 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 2 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM MITRAL 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 11174369 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 5 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL 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 11055998 ↗

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