MOSAIC® 310C25 (UDI 00885074242507)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00885074242507), received between Nov 20, 2017 and Sep 2, 2025 — classified as 31 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (19 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR INTERVENTION FOR BOTH VALVES AS STRUCTURAL VALVE DYSFUNCTION (SVD). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22937178 ↗
• InjuryJul 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS POST IMPLANT OF THIS MOSAIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS LOW EJECTION FRACTION (EF). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22402870 ↗
• InjuryJul 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 3 MONTHS POST IMPLANT OF THIS MOSAIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22402802 ↗
• InjuryJul 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 7 MONTHS POST IMPLANT OF THIS MOSAIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS LOW EJECTION FRACTION (EF). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22402726 ↗
• MalfunctionJul 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 9 MONTHS POST IMPLANT OF THIS MOSAIC VALVE, THE PATIENT IS BEING EVALUATED 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 22371668 ↗
• InjuryDec 9, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS MITRAL STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Stenosis

  MAUDE report 20879335 ↗
• InjuryOct 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 7 MONTHS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM 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 20473986 ↗
• InjuryOct 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 1 MONTH POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A DIFFERENT MANUFACTURERS PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20410456 ↗
• InjuryAug 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT HAD OCCASIONAL ATRIAL FIBRILLATION. MEDICATION WAS PRESCRIBED. SUBSEQUENTLY, 4 DAYS LATER, A PERMANENT PACEMAKER WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 20011848 ↗
• InjuryApr 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 14 DAYS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS BRADYCARDIA , TACHYCARDIA, ATRIAL FIBRILLATION (AFIB), AND ATRIAL FLUTTER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Bradycardia; Tachycardia

  MAUDE report 19053731 ↗
• InjuryMar 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 4 MONTHS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM 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 18967126 ↗
• InjuryOct 13, 2023Perivalvular Leak; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Perivalvular Leak; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 16 YEARS AND 3 MONTHS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A FOR A POTENTIAL REPLACEMENT. DURING THE EVALUATION IT WAS REPORTED THAT THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED AN ENLARGED RIGHT VENTRICLE, RIGHT VENTRICULAR SYSTOLIC FUNCTION NORMAL, LEFT ATRIUM IS MODERATELY TO SEVERELY DILATED, MITRAL VALVE RING DEHISCENCE AND PERFORATION OF ANTERIOR AND POSTERIOR VALVE LEAFLETS, RUPTURED CORDS, SEVERE MITRAL REGURGITATION (MR), MEAN MITRAL VALVE GRADIENT OF 6.4MMHG, MITRAL STENOSIS(MS), LEFT ATRIAL APPENDAGE HAS BEEN SUTURED, WITH DOPPLER EVIDENCE OF FLOW AT THE EDGES OF THE SUTURES AND A THROMBUS SEEN IN THE LEFT ATRIUM. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Stenosis; Thrombosis/Thrombus; Valvular Insufficiency/ Regurgitation

  MAUDE report 17934718 ↗
• InjurySep 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 7 MONTHS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17788607 ↗
• InjurySep 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIAL FIBRILLATION AND SINUS BRADYCARDIA-TACHYCARDIA SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 17675739 ↗
• InjurySep 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 4 MONTHS POST IMPLANT OF THIS 25MM 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 17675690 ↗
• InjurySep 4, 2023Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS SEVERE MITRAL REGURGITATION AND CONGESTIVE HEART FAILURE. IT WAS ALSO REPORTED THAT THERE WAS DETERIORATION OF THE VALVE LEAFLETS AS ONE LEAFLET HAD TORN AND BECOME A FLAIL LEAFLET. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMS OF EDEMA, DYSPNEA WITH EXERTION AND HEART FAILURE SYMPTOMS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cusp Tear; Dyspnea; Heart Failure/Congestive Heart Failure; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Swelling/ Edema

  MAUDE report 17675598 ↗
• InjuryMay 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS SEVERE AORTIC INSUFFICIENCY WITH MILD AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 17020933 ↗
• InjuryJan 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 5 MONTHS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM 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 16094255 ↗
• InjuryFeb 28, 2022Gradient Increase; Naturally Worn; Insufficient Device Problem Information; Gradient Increase; Naturally Worn; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 6 MONTHS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM 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 Insufficiency/ Regurgitation; Mitral Valve Stenosis

  MAUDE report 13619856 ↗
• InjuryFeb 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 2 MONTHS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE PULMONARY POSITION IN A (B)(6) YEAR OLD PEDIATRIC PATIENT, A 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; Pulmonary Valve Stenosis

  MAUDE report 13584967 ↗
• InjuryNov 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 12 YEARS AND 2 MONTHS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12731946 ↗
• InjuryJun 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 4 MONTHS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM 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 12084114 ↗
• InjuryFeb 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 10 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC MITRAL VALVE IMPLANTED IN THE PULMONARY POSITION OF A (B)(6) YEAR OLD PATIENT, BALLOON VALVULOPLASTY WAS PERFORMED. PRIOR TO VALVULOPLASTY, THE VALVE HAD A 45 MMHG GRADIENT, STENOSIS AND MODERATE TO SEVERE VALVULAR INSUFFICIENCY. FOLLOWING THE VALVULOPLASTY, THERE WAS A 15-20MMHG GRADIENT, AND NO CHANGE IN THE INSUFFICIENCY. NO ADDITIONAL INTERVENTIONS WERE PERFORMED AT THAT TIME. ULTIMATELY, 10 YEARS AND 7 MONTHS POST IMPLANT, A TRANSCATHETER PULMONARY VALVE (TPV) WAS IMPLANTED VALVE-IN-VALVE DUE TO MILD-TO-MODERATE STENOSIS AND MODERATE INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 9664907 ↗
• InjuryJan 7, 2020Gradient Increase; Off-Label Use; Material Too Rigid or Stiff; Gradient Increase; Off-Label Use; Material Too Rigid or Stiff

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 4 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC MITRAL VALVE IMPLANTED IN THE PULMONARY POSITION OF A 13 YEAR OLD, A TRANSCATHETER PULMONARY VALVE (TPV) WAS IMPLANTED VALVE-IN-VALVE. THE VALVE WAS REPLACED DUE TO MODERATE STENOSIS WITH ELEVATED GRADIENTS. IT WAS REPORTED THAT THE LEAFLETS APPEARED THICKENED AND IMMOBILE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 9560803 ↗
• InjuryOct 15, 2019Gradient Increase; Off-Label Use; Gradient Increase; Off-Label Use

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 9 MONTHS POST IMPLANT OF THIS 25MM BIOPROSTHETIC VALVE IN THE TRICUSPID POSITION OF A 13-MONTH-OLD PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS PROGRESSIVELY INCREASING GRADIENTS (12 TO 15MMHG). IT WAS ALSO NOTED THAT THERE WAS MINIMAL TRICUSPID VALVE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Regurgitation

  MAUDE report 9194066 ↗

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-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-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