MOSAIC® 310C31 (UDI 00643169001596)Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00643169001596), received between Jan 3, 2017 and Sep 21, 2026 — classified as 3 deaths, 60 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (42 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• DeathSep 21, 2026Insufficient Device Problem Information

  Medtronic received information that an unknown duration post implant of this 31mm Mosaic heart valve, the patient died. The cause of death was not received. Therefore, relatedness of the death to the Mosaic heart valve could not be excluded. It is unknown whether an autopsy was performed.

  Patient problems: Insufficient Information

  MAUDE report 50840634 ↗
• 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 50691484 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem; Device Stenosis

  Medtronic received information that an unknown duration post implant of this 31mm mitral bioprosthetic valve, it was explanted and replaced with a new 31mm 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; Mitral Valve Stenosis

  MAUDE report 50070559 ↗
• InjuryApr 17, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT (B)(6) POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SINUS BRADYCARDIA-TACHYCARDIA SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED

  Patient problems: Bradycardia; Tachycardia

  MAUDE report 24916383 ↗
• InjuryApr 2, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, THE PHYSICIAN NOTICED A MILD CENTRAL MITRAL REGURGITATION. IT WAS STATED THAT THE "PHYSICIAN WOULD LIKE TO SEE TESTING VIDEO TO CONFIRM THE VALVE'S LEAFLET COAPTATION". NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24765276 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 11 YEARS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NEW 31MM MI TRAL 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; Stenosis; Valvular Insufficiency/ Regurgitation

  MAUDE report 24520065 ↗
• InjuryNov 24, 2025Calcified; Material Split, Cut or Torn; Intravalvular regurgitation; Calcified; Material Split, Cut or Torn; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 2 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN VALVE PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS CALCIFICATION AND DAMAGED LEAFLETS, AS 2 LEAFLETS HAD HOLES IN THEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Cusp Tear; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23639583 ↗
• InjuryFeb 6, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT POST IMPLANT OF A MOSAIC MITRAL VALVE, THE PATIENT WAS BEING EVALUATED FOR A POSSIBLE MITRAL VALVE REPLACEMENT WITH ANOTHER MANUFACTURERS DEVICE. THE PATIENT WAS EXPERIENCING INCREASED SHORTNESS OF BREATH WITH MODERATE EXERTION OVER THE PAST FEW MONTHS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 21321589 ↗
• InjuryDec 13, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 6 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS PRIMARY PREVENTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20928603 ↗
• InjuryNov 29, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 5 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE AND 1 YEAR AND 6 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, A BI-VENTRICULAR DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE BI-VENTRICULAR DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 20809173 ↗
• InjuryNov 14, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 4 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS 3RD DEGREE ATRIOVENTRICULAR BLOCK AND ATRIAL ARRHYTHMIA (ATRIAL TACHYCARDIA, ATRIAL FIBRILLATION, ATRIAL FLUTTER). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Heart Block; Insufficient Information; Non specific EKG/ECG Changes

  MAUDE report 20686205 ↗
• InjuryNov 4, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 2 MONTHS POST IMPLANT OF THIS MITRAL BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS MITRAL REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20605264 ↗
• InjuryOct 28, 2024Material Separation; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Material Separation; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS SEVERE MITRAL INSUFFICIENCY DUE TO VALVE DEHISCENCE WITH ATRIAL-VENTRICULAR DEHISCENCE AND FALSE ANEURYSM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20545050 ↗
• InjuryOct 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENTS SPOUSE THAT 10 YEARS AND 6 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A DIFFERENT MANUFACTURERS MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20485487 ↗
• InjuryOct 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 2 MONTHS 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) AND ATRIAL ARRYTHMIAS INDICATED AS BEING ATRIAL TACHYCARDIA, ATRIAL FLUTTER AND ATRIAL FIBRILLATION (AFIB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 20480833 ↗
• InjuryOct 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 11 MONTHS 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) AND ATRIAL ARRYTHMIAS INDICATED AS BEING ATRIAL TACHYCARDIA, ATRIAL FLUTTER AND ATRIAL FIBRILLATION (AFIB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 20480157 ↗
• InjurySep 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 4 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE VALVE WAS FAILING AND IS PLANNED TO BE REPLACED. THE REASON FOR REPLACEMENT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20234715 ↗
• InjuryMay 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 3 MONTHS POST IMPLANT OF THIS 31MM 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 19284617 ↗
• InjuryMay 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 16 YEARS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THAT THE REASON FOR REPLACEMENT WAS RECURRENT SEVERE SYMPTOMATIC MITRAL REGURGITATION (MR) AND MILDLY REDUCED EJECTION FRACTION (EF). IT WAS REPORTED THAT THE PATIENT REQUIRED THREE DEFIBRILLATIONS AND TWO UNITS OF PLATELETS FOLLOWING REPLACEMENT OF THE RING. IT WAS FURTHER REPORTED THAT THERE WAS ONGOING BLEEDING WITH A RETAINED HEMOTHORAX POST PROCEDURE ON THE SAME DAY. IT WAS NOTED THAT DURING THE MITRAL VALVE REPLACEMENT PROCEDURE THAT DAY THAT THE PATIENT HAD EXTENSIVE PULMONARY ADHESIOLYSIS. IT WAS STATED THAT THERE WAS TWO BLEEDING SITES FROM THE APEX OF LUNG AND CHEST FROM ADHESIOLYSIS. A REOPENING OF THE RECENT THORACOTOMY, EVACUATION OF THE RETAINED HEMOTHORAX AND WASHOUT OF PLEURAL SPACES WAS PERFORMED. IT WAS STATED THAT A SIGNIFICANT AMOUNT OF RETAINED CLOT WAS EVACUATED FROM THE RIGHT PLEURAL SPACE. IT WAS NOTED THAT PLEDGETED REPAIR OF PULMONARY BLEEDING AT THE

  Patient problems: Hemothorax; Non specific EKG/ECG Changes

  MAUDE report 19229508 ↗
• InjuryFeb 15, 2024Incomplete Coaptation; Thickening of Material; Incomplete Coaptation; Thickening of Material

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 1 YEAR POST IMPLANT OF THIS 31MM BIOPROSTHETIC MITRAL VALVE, MULTIDETECTOR COMPUTED TOMOGRAPHY (CT) REVEALED THICKENING OF LEAFLET #2 BY 6.7MM RESULTING IN PARTIAL RESTRICTION AND THICKENING OF LEAFLET #3 BY 8.4MM RESULTING IN A LARGELY IMMOBILE LEAFLET. NO INTERVENTIONS OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY THE PATIENT WAS STARTED ON ANTI-COAGULATION MEDICATION AS A RESULT OF THIS FINDING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18711473 ↗
• InjuryFeb 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS AND 4 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18659252 ↗
• InjuryJan 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 5 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE IN THE TRICUSPID LOCATION, 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 18459328 ↗
• InjuryOct 31, 2023Insufficient 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 8 YEARS AND 3 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM VALVE OF THE SAME MAKE AND 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 18039835 ↗
• InjuryAug 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 10 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRIC USPID POSITION, 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 17562642 ↗
• InjuryJul 28, 2023Perivalvular Leak; Insufficient Device Problem Information; Perivalvular Leak; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 8 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED WITH A 33MM BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THAT REASON FOR REPLACEMENT WAS MILD PARAVALVULAR TRICUSPID REGURGITATION AND MODERATE TRICUSPID STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 17414046 ↗

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