MOSAIC® 310C27 (UDI 00643169001633)Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00643169001633), received between Jan 4, 2017 and Sep 23, 2026 — classified as 7 deaths, 48 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (35 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 57 reports, in the reporter's own words as published by the FDA.

• DeathSep 23, 2026Insufficient Device Problem Information

  It was reported that during the implant of this 27mm mitral bioprosthetic valve, it was explanted and replaced with a new 27mm mitra l bioprosthetic valve of the same model or vice versa. The reason for the replacement was not reported. It was further reported that on the same day the patient was reported deceased. It was noted that the mitral device which remained implanted in the patient was unconfirmed. The cause of death was not received. Therefore, relatedness of the death to the valves could not be excluded. It is unknown whether an autopsy was performed.

  Patient problems: Insufficient Information

  MAUDE report 50866010 ↗
• InjurySep 22, 2026Patient Device Interaction Problem

  Medtronic received information that 2 years and 2 months post implant of this 27mm mitral bioprosthetic heart 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 50851500 ↗
• DeathMay 21, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 29 MM AORTIC BIOPROSTHETIC VALVE AND 27 MM MITRAL BIOPROSTHETIC VALVE, THE PATIENT WAS REPORTED DECEASED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE VALVES COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 25239569 ↗
• InjuryMay 19, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE SAME POSITION OR VICE-VERSA. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25212790 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 10 MONTHS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 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

  MAUDE report 25182016 ↗
• InjuryMar 26, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 10 DAYS POST IMPLANT OF THIS 27MM 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 24696857 ↗
• InjuryMar 13, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR BLOCK AND ATRIAL ARRYTHMIAS (ATRIAL TACHYCARDIA (AT), ATRIAL FIBRILLATION (AF) AND ATRIAL FLUTTER (A-FL)). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Tachycardia

  MAUDE report 24597821 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 12 YEARS AND 9 MONTHS POST IMPLANT OF THIS 27MM 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 24302321 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 12 YEARS AND 5 MONTHS POST IMPLANT OF THIS 27 MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 30MM TRICUSPID ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23862567 ↗
• MalfunctionNov 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 9 MONTHS POST IMPLANT OF THIS MITRAL BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVAL UATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23450927 ↗
• InjurySep 12, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT 8 YEARS AND 7 MONTHS POST IMPLANT OF THIS MOSAIC MITRAL VALVE, A COMPETITORS TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC STENOSIS (AS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 23036754 ↗
• MalfunctionJan 23, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT 6 YEARS AND 11 MONTHS POST IMPLANT OF A 27MM MITRAL BIOPROSTHETIC VALVE, MODERATE MITRAL VALVE STENOSIS AND MILD TRICUSPID REGURGITATION WERE OBSERVED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Mitral Valve Stenosis

  MAUDE report 21218258 ↗
• InjuryDec 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 11 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE AND 27MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS BRADYCARDIA TACHYCARDIA SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Tachycardia

  MAUDE report 20930440 ↗
• InjuryDec 12, 2024Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS 3RD DEGREE ATRIOVENTRICULAR BLOCK OR COMPLETE HEART BLOCK AND ATRIAL ARRHYTHMIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block; Insufficient Information

  MAUDE report 20916275 ↗
• InjuryAug 7, 2024Calcified; Insufficient Device Problem Information; Material Split, Cut or Torn; Device Stenosis; Calcified; Insufficient Device Problem Information; Material Split, Cut or Torn; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 2 MONTHS POST IMPLANT OF THIS 27MM 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: Calcium Deposits/Calcification; Cusp Tear; Insufficient Information; Mitral Valve Stenosis

  MAUDE report 19934149 ↗
• InjuryApr 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME. IT WAS ALSO REPORTED BY THE PATIENT THAT THEY HAVE MOMENTS OF ATRIAL FIBRILLATION (A.FIB) AND THEIR HEART RATE FLUCTUATES FROM 40 - 120 BPM.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19182980 ↗
• InjuryMar 27, 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 P ATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18985275 ↗
• InjuryFeb 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY POST IMPLANT OF A 25MM MITRAL BIOPROSTHETIC VALVE, THE PATIENT DIED. IT WAS REPORTED THAT A 27MM MITRAL BIOPROSTHETIC VALVE WAS INITIALLY IMPLANTED, HOWEVER, FOLLOWING ITS IMPLANT, BRIGHT RED BLOOD COULD BE SEEN COMING FROM THE BACK OF THE HEART. A HEMATOMA WAS DISCOVERED ON THE BACK OF THE HEART WITH BLOOD COMING FROM THE ATRIO-VENTRICULAR (AV) GROOVE CONSISTENT WITH AV DISSOCIATION. IT WAS STATED THAT THE PATIENT EXPERIENCED CARDIOGENIC SHOCK, ACUTE BLOOD LOSS ANEMIA AND COAGULOPATHY. THE PATIENT WAS RE-CROSS CLAMPED, THE SUPERIOR VENA CAVA (SVC) AND IVC RE-CANNULATED, AND THE HEART WAS ARRESTED. THE 27MM VALVE WAS REMOVED AND IT WAS REPORTED THAT THERE WERE TWO AREAS WHERE IT WAS OBSERVED THAT THE VALVE SUTURES HAD PULLED THROUGH THE TISSUE AND THERE WAS DISRUPTED ENDOCARDIUM IN TWO AREAS. IT WAS MENTIONED THAT THE REMAINDER OF THE AV GROOVE APPEARED INTACT AND THE POSTERIOR LEAFLET AND CHORDAE WERE INTACT AND HAD NOT BEEN REMOVED. THE AREAS WERE REPAIRED WITH MULTIPLE PLEDGETTED MATTRESS SUTURES. THE VALVE WAS REPLACED WITH A 25MM VALVE OF THE SAME MODEL. IT WAS OBSERVED THAT BRIGHT RED BLOOD CONTINUED TO COME FROM THE AV GROO

  Patient problems: Anemia; Bradycardia; Cardiogenic Shock; Coagulation Disorder; Hematoma; Hemorrhage/Blood Loss/Bleeding; Tachycardia

  MAUDE report 18668563 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY POST IMPLANT OF THESE 27MM MITRAL AND 31MM TRICUSPID BIOPROSTHETIC VALVES, 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: Cardiac Arrest; Heart Block; Pneumothorax

  MAUDE report 18454734 ↗
• InjuryDec 14, 2023Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 6 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN AORTIC VALVE OF A DIFFERENT MANUFACTURE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS STENOSIS. DURING THE SAME OPERATION IT WAS ALSO NOTED THAT 7 YEARS AND 6 MONTHS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN MITRAL VALVE OF A DIFFERENT MANUFACTURE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS STENOSIS. THE PATIENT ALSO HAD A 30MM ANNULOPLASTY BAND PLACED IN THE NATIVE TRICUSPID LOCATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 18328642 ↗
• InjuryJul 5, 2023Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 5 MONTHS POST IMPLANT OF THIS 27MM 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; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17256534 ↗
• InjuryJun 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 3 MONTHS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, THE PATIENT IS GOING TO RECEIVE A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY 2 DAYS LATER, A DIFFERENT MANUFACTURERS TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS MODERATE MITRAL INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17241697 ↗
• InjuryMay 17, 2023Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THAT THE REASON FOR THE REPLACEMENT WAS SEVERE MITRAL REGURGITATION WITH THE PRESENCE OF LARGE VEGETATION VS THROMBUS ON A VALVE LEAFLET AND ONE OF THE LEAFLETS APPEARED TORN. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED SEPSIS, NON-SUSTAINED VENTRICULAR TACHYCARDIA AND ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. IT WAS INDICATED THAT AMIODARONE WAS ADMINISTERED. IT WAS STATED THAT BLOOD CULTURES WERE NEGATIVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Cusp Tear; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Sepsis; Tachycardia

  MAUDE report 16945731 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 WEEK POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS NYHA CLASS III. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 16756104 ↗
• DeathApr 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 8 MONTHS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THERE WAS NO EVIDENCE TO SUGGEST THAT THE VALVE OR ITS FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 16752417 ↗

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