MOSAIC® 310C29 (UDI 00613994688927)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00613994688927), received between Nov 30, 2017 and Jun 29, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 4 MONTHS POST IMPLANT OF THIS 29MM MOSAIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER NOT REPORTED AS COMPLETE HEART BLOCK (CHB), ATRIAL FIBRILLATION (AF), ATRAIL TACHYCARDIA (AT) AND ATRIAL FLUTTER (A-FL). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Heart Block; Tachycardia

  MAUDE report 25649943 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT 14 YEARS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cusp Tear; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24673361 ↗
• InjuryJul 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENTS SPOUSE THAT 9 YEARS AND 4 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE IMPLANTED INT HE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22577530 ↗
• InjuryJul 1, 2024Insufficient Device Problem Information; Material Split, Cut or Torn; Intravalvular regurgitation; Insufficient Device Problem Information; Material Split, Cut or Torn; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 7 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cusp Tear; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19649897 ↗
• InjuryMar 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 1 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM 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 18987970 ↗
• InjuryMay 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THAT THE REASON FOR REPLACEMENT WAS STRUCTURAL VALVE DEGENERATION SECONDARY TO PANNUS FORMATION OVER THE SEWING CUFF AND INVOLVING THE BIOPROSTHETIC LEAFLETS. IT WAS REPORTED THAT ONE OF THE THREE LEAFLETS APPEARED TO BE DYSFUNCTIONAL AND SLIGHTLY MALFORMED SECONDARY TO THE PANNUS OVERREACH.

  Patient problems: Foreign Body Reaction; Insufficient Information

  MAUDE report 16919758 ↗
• InjuryFeb 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS SEVERE MITRAL STENOSIS AND SEVERE MITRAL REGURGITATION. IT WAS ALSO REPORTED THAT THE PATIENT HAD AN EJECTION FRACTION BETWEEN 45%-65% AND A MEAN GRADIENT OF 9MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 16428403 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 DAYS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 15915568 ↗
• InjuryNov 30, 2022Gradient Increase; Insufficient Device Problem Information; Material Split, Cut or Torn; Gradient Increase; Insufficient Device Problem Information; Material Split, Cut or Torn

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 4 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: Cusp Tear; Endocarditis; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15884569 ↗
• InjuryOct 31, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE 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 15701353 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED TO BE DUE TO HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 13842122 ↗
• InjuryMar 17, 2022Insufficient 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 24MM MITRAL MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13790685 ↗
• InjuryMar 4, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 10 MONTHS POST IMPLANT OF THIS 29MM BIOPROSTHETIC MITRAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS REPORTED AS A TORN LEAFLET. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9786147 ↗
• InjuryMay 8, 2019Adverse 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 8 YEARS AND 6 MONTHS POST IMPLANT OF THIS 29MM BIOPROSTHETIC MITRAL VALVE, IT WAS EXPLANTED AND REPLACED WITH 31MM BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. THE REASON FOR REPLACEMENT WAS NOT PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Mitral Insufficiency; No Information

  MAUDE report 8591630 ↗
• InjuryDec 26, 2018Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT SEVEN YEARS AND TEN MONTHS POST IMPLANT OF THIS 29MM BIOPROSTHETIC MITRAL VALVE, IT WAS EXPLANTED AND REPLACED WITH 31MM VALVE OF THE SAME MODEL. THE VALVE WAS REPLACED DUE TO SIGNIFICANT REGURGITATION AND CALCIFICATION. IT WAS REPORTED THAT THE INSUFFICIENCY WAS DUE TO IV DRUG ABUSE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Host-Tissue Reaction; Mitral Insufficiency; Mitral Regurgitation; Regurgitation

  MAUDE report 8196012 ↗
• InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS 1 MONTH POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE DUE TO REGURGITATION AND RECENT STAPH AUREUS ENDOCARDITIS. THE PATIENT HAD DEVELOPED SHORTNESS OF BREATH AND LOWER EXTREMITY EDEMA AND WAS PLACED ON ANTIBIOTICS. THE PATIENT HAD A MURMUR THAT HAD BECOME MORE PRONOUNCED AND DEMONSTRATED SIGNIFICANT PROSTHETIC VALVE MITRAL REGURGITATION, WHICH REQUIRED A MITRAL VALVE REPLACEMENT. THE VALVE WAS SENT TO THE HOSPITAL LAB FOR CULTURES NO ANAEROBES WERE ISOLATED AND NO GROWTH RESULTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Mitral Regurgitation

  MAUDE report 7822945 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 2 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A VALVE OF THE SAME MODEL AND SIZE. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7071007 ↗

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