MOSAIC® 310C31 (UDI 00643169594869)Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00643169594869), received between Jan 30, 2017 and Sep 9, 2026 — classified as 11 deaths, 106 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (68 reports).

1 FDA recall record name this device's identifier.

2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 21, 2019Terminated

   Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.

   Z-1881-2019 · Root cause: Labeling mix-ups · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Patient Device Interaction Problem

  Medtronic received information that 2 days post implant of these 31mm Mosaic heart valves, a leadless pacemaker was implanted. The reason for the leadless pacemaker was reported as 3rd degree AV Block (AVB) and Complete Heart Block (CHB). No additional adverse patient effects were reported.

  Patient problems: Heart Block

  MAUDE report 50691492 ↗
• InjuryMay 15, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 4 MONTHS POST IMPLANT OF THIS 31MM MOSAIC MITRAL BIOPROSTHETIC VALVE IN THE TRICUSPID POSITION, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. INTERVENTION IS SCHEDULED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 25182617 ↗
• InjuryApr 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 YEARS AND 7 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, A LEADLESS PACEMAKER WAS IMPLANTED. THE REASON FOR THE LEADLESS PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 24999496 ↗
• InjuryMar 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 YEAR AND 8 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, A LEADLESS PACEMAKER WAS IMPLANTED. THE REASON FOR THE LEADLESS PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 24647700 ↗
• MalfunctionMar 11, 2026Leak/Splash; Unsealed Device Packaging

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT WHEN THE VALVE BOX WAS OPENED, THE VALVE JAR APPEARED TO BE LEAKING. THE YELLOW TAMPER STRIP ON THE VALVE WAS CUT BY A HEALTH CARE PROFESSIONAL. THE VALVE WAS NOT USED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567865 ↗
• InjuryFeb 27, 2026Adverse 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 TRICUSPID STENOSIS AND SEVERE TRICUSPID REGURGITATION DUE TO PROSTHETIC VALVE ENDOCARDITIS. THE ORGANISM CULTURED WAS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information; Tricuspid Valve Insufficiency/ Regurgitation; Tricuspid Valve Stenosis

  MAUDE report 24470833 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24443665 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 5 YEARS AND 7 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 33MM 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 24376308 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BI OPROSTHETIC VALVE OF THE SAME MODEL. IT WAS ALSO REPORTED THAT THE VALVE WAS WASTED AND NOT IMPLANTED IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24305314 ↗
• InjuryFeb 10, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 1 MONTH POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC 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 24305149 ↗
• InjuryJan 30, 2026Perivalvular Leak; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR REPLACEMENT WAS "PARAVALVULAR LEAK DUE THE IMUNOSUPPRESANTS FOR LUPUS". IT WAS REPORTED THAT THE PHYSICIAN STATED EMPHATICALLY THAT THIS EVENT HAD NOTHING TO DO WITH THE 31MM MITRAL BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Autoimmune Disorder; Insufficient Information; Valvular Insufficiency/ Regurgitation

  MAUDE report 24220348 ↗
• InjuryDec 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION ON THE SAME DAY, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS VALVE DISEASE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23776194 ↗
• DeathNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE PATIENTS CAUSE OF DEATH WAS CONFIRMED AS RIGHT SIDED HEART FAILURE. IT WAS ALSO REPORTED THAT THE PATIENT HAD CONTRIBUTING FACTORS SUCH AS CHRONIC RIGHT SIDED HEART FAILURE, PNEUMONIA, CONGESTIVE HEART FAILURE AND A GASTROINTESTINAL BLEED. IT WAS FURTHER NOTED THAT THE PHYSICIAN DOES NOT BELIEVE THE MEDTRONIC PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pneumonia

  MAUDE report 23634272 ↗
• InjuryNov 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, 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 23534758 ↗
• InjuryOct 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 DAYS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 23412632 ↗
• InjuryOct 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 28 DAYS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23310937 ↗
• DeathSep 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 9 MONTHS POST IMPLANT OF THIS MOSAIC MITRAL VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE MOSAIC VALVE COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED

  Patient problems: Insufficient Information

  MAUDE report 23050138 ↗
• InjurySep 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS AND 5 MONTHS POST IMPLANT OF THIS 31MM MOSAIC MITRAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 33MM MOSAIC MITRAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22992711 ↗
• InjuryAug 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIOVENTRICULAR BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22898998 ↗
• InjuryAug 18, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR REPLACEMENT AS TRICUSPID REGURGITATION (TR). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 22825847 ↗
• InjuryJul 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 1 MONTH POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED SICK SINUS SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22637311 ↗
• InjuryJun 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 WEEK 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 22318045 ↗
• MalfunctionJun 17, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT AN UNKNOWN COMPOUND WAS DISCOVERED ON THE OUTSIDE OF A MOSAIC MITRAL VALVE JAR. THE DEVICE WAS NEVER IMPLANTED. IT WAS FURTHER REPORTED THAT THE UNKNOWN COMPOUND WAS ONLY PRESENT ON THE OUTSIDE OF THE JAR. THE VALVE WAS STORED IN A CABINET WITH TEMPERATURES APPROXIMATELY 51-61 DEGREES. IT WAS STATED THAT THERE WAS NO LEAK ON THE VALVE JAR AND THE DEVICE REMAINED STERILE. NO OTHER VALVES STORED IN THIS AREA HAD THIS ISSUE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22242544 ↗
• InjuryJun 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 31MM MITRAL 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 22186332 ↗
• InjuryMar 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT INDICATED THAT A PATIENT THAT WAS IMPLANTED WITH A 27MM BIOPROSTHETIC VALVE, 31MM BIOPROSTHETIC VALVE AND 32MM TRICUSPID ANNULOPLASTY BAND ALSO HAD A PERMANENT PACEMAKER OF A DIFFERENT MANUFACTURER IMPLANTED. THE REASON FOR THEPERMANENT PACEMAKER WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 21570800 ↗

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-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