MOSAIC® 310C25 (UDI 00643169594838)Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00643169594838), received between Feb 13, 2017 and Sep 25, 2026 — classified as 14 deaths, 38 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (31 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 56 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Intravalvular regurgitation

  It was reported that 9 years and 2 months post implant of this 25mm mitral bioprosthetic valve implanted in the tricuspid position, the patient received a replacement. The reason for intervention was reported as regurgitation. No additional adverse patient effects were reported.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 50896603 ↗
• InjuryMay 25, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 6 DAYS POST IMPLANT OF THIS 25 MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR BLOCK (AV). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 25269392 ↗
• InjuryMar 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 DAYS POST IMPLANT OF THIS 25MM 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 24647626 ↗
• InjuryMar 12, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 5 DAYS POST IMPLANT OF THIS 25MM 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 24579385 ↗
• InjuryMay 19, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT POST IMPLANT OF THIS 25MM MOSAIC MITRAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM MOSAIC MITRAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Stenosis

  MAUDE report 22042690 ↗
• DeathMay 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE VALVE COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 21941808 ↗
• InjuryFeb 25, 2025Insufficient Device Problem Information; Thickening of Material; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Thickening of Material; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THE PATIENT IS BEING EVALUATED FOR A POSSIBLE TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC REGURGITATION (AR). IT WAS MENTIONED THAT POSSIBLE PANNUS/THROMBUS WAS OBSERVED ON THE AORTIC VALVE. ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THAT 6 WEEKS LATER, THE 19MM AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED AND REPLACED WITH A 23MM VALVE OF THE SAME MODEL. IT WAS FURTHER REPORTED THAT 4 YEARS AND 5 MONTHS POST IMPLANT OF THE PATIENTS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS ALSO EXPLANTED AND REPLACED WITH A 29MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT OF THE MITRAL VALVE WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21458123 ↗
• InjuryFeb 12, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

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

  Patient problems: Insufficient Information; Perforation

  MAUDE report 21365407 ↗
• MalfunctionNov 20, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE PROCEDURE OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE CINCH MECHANISM WAS TIGHTENED AND THE SUTURE BROKE BEFORE THE SURGEON PLACED ANY SUTURES. IT WAS ALSO REPORTED THAT THE SURGEON WAS UNSURE IF THEY OVERTIGHTENED THE CINCH MECHANISM OR NOT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20738364 ↗
• MalfunctionNov 19, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, THE SUTURE BROKE DURING INITIAL LOADING AND TIGHTENING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722247 ↗
• DeathOct 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY AS THE IMPLANT DATE OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, THE PATIENT DIED. 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 20545282 ↗
• MalfunctionSep 23, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN DURING USAGE OF THE CINCH. THE VALVE WAS NEVER IMPLANTED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20286071 ↗
• InjuryAug 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20010264 ↗
• MalfunctionJul 22, 2024Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE VALVE WAS KEPT IN A STOREROOM BETWEEN THEATRES ON A WIRED SHELF IN WIRED OPEN CONTAINERS. IT WAS REPORTED THAT THE VALVE JAR APPEARED TO BE CRACKED WITH FLUID STILL REMAINING WITHIN THE JAR. THE SEAL ON THE VALVE JAR WAS NOT BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793324 ↗
• InjuryJul 2, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 9 MONTHS POST IMPLANT OF THIS 25MM 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; Mitral Valve Stenosis

  MAUDE report 19660596 ↗
• DeathApr 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS RECEIVED AS CARDIOGENIC SHOCK, STAPHYLOCOCCUS AUREUS BACTEREMIA AND SEPSIS. THEREFORE, RELATEDNESS OF THE DEATH TO THE 25MM MIT RAL BIOPROSTHETIC VALVE COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED

  Patient problems: Cardiogenic Shock; Sepsis

  MAUDE report 19202830 ↗
• InjuryMar 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 6 MONTHS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION IN A THEN 7 YEAR OLD PEDIATRIC PATIENT, A 18MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18967243 ↗
• InjuryFeb 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 7 MONTHS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18686428 ↗
• InjuryFeb 9, 2024Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 25MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MITRAL REGURGITATION. IT WAS STATED THAT THE MITRAL VALVE WAS QUITE DELICATE WITH VERY FLIMSY TISSUES. AFTER VALVE REPLACEMENT, SIGNIFICANT PERIVALVULAR LEAK (PVL) WAS OBSERVED AT THE P1-P2 AREA JUST OUTSIDE THE ANNULUS. FIVE ADDITIONAL SUTURES WERE PLACED TO REINFORCE THE REINFORCE THE SUTURES COVERING THE AREA OF THE ANTEROLATERAL COMMISSURE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SUBSEQUENTLY CARRIED OUT REVEALED NO PARAVALVULAR LEAK (PVL). IT WAS MENTIONED THAT THE PATIENT IS IN CRITICAL CONDITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 18677522 ↗
• DeathFeb 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: Cardiac Arrest

  MAUDE report 18668651 ↗
• InjuryNov 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, AN ECHOCARDIOGRAM NOTED THE PRESENCE OF SEVERE AORTIC INSUFFICIENCY. IT WAS THOUGHT THAT ONE OF THE MITRAL VALVE SUTURES CAUGHT THE AORTIC VALVE LEAFLETS AND IT WAS REPORTED THAT UPON EXPOSING THE AORTIC VALVE, THE NON CORONARY LEAFLET WAS OBSERVED TO HAVE TORN AWAY AT THE COMMISSURE OF THE NON CORONARY TO LEFT CORONARY. A PLEDGETED SUTURE WAS ALSO OBSERVED IN THIS AREA AND THE SUTURE HAD ALSO TETHERED THE LEFT CORONARY LEAFLET. A 21MM AORTIC BIOPROSTHETIC VALVE WAS IMPLANTED TO TREAT THE SEVERE AORTIC INSUFFICIENCY. IT WAS ALSO REPORTED THAT THE PATIENT WAS PLACED ON AN INTRA-AORTIC BALLOON PUMP (IABP) DUE TO CARDIOGENIC SHOCK AND LEFT VENTRICULAR DYSFUNCTION. IT WAS INDICATED THAT PRIOR TO THE IMPLANT OF THIS 25MM MITRAL VALVE, A POSTERIOR ATRIOVENTRICULAR GROOVE DISRUPTION HAD BEEN CREATED WHILE EXPLANTING THE PRE-EXISTING MITRAL VALVE WHICH WAS SUBSEQUENTLY REAPPROXIMATED USING THE VALVE SUTURES FOR THE MITRAL VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiogenic Shock

  MAUDE report 18047360 ↗
• InjuryOct 31, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 3 WEEKS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, THE PATIENT WAS HOSPITALIZED FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE. IT WAS REPORTED THAT THE PATIENT WAS PUT ON A DRIP WITH ANTIARRHYTHMIC MEDICATION AND CONVERTED BACK TO SINUS RHYTHM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 18037794 ↗
• InjuryOct 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 DAYS POST IMPLANT OF THIS 25MM 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 18019366 ↗
• InjurySep 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17768988 ↗
• InjuryJun 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS THE VALVE POST WAS DISPLACED IN THE LEFT ATRIUM. THE VALVE WAS EXPLANTED AND REPLACED WITH A DIFFERENT MANUFACTURERS PRODUCT. IT WAS ALSO REPORTED THAT THERE WAS NO MALFUNCTION AND NO FAILURE OF THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17239671 ↗

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