MOSAIC® 310C33 (UDI 00643169594876)Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00643169594876), received between Apr 4, 2018 and Jun 24, 2026 — classified as 4 deaths, 52 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (40 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Patient Device Interaction Problem

  ON (B)(6) 2026 CHAUHR6 - THIS SR WAS CREATED TO CAPTURE PERMANENT PACEMAKER IMPLANTED ON (B)(6) 2026 NOTICED ON DIQ WHILE REVIEWING THIS SR/PE 0609157210. THE AWARE DATE WAS SET TO TODAYS WHEN NOTICED ON DIQ.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Cardiomyopathy; Heart Block; Tachycardia

  MAUDE report 25608880 ↗
• MalfunctionMay 4, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE, THE CINCH STRINGS BROKE ON TWO 33MM MOSAIC MITRAL VALVES. IT WAS REPORTED THAT THE FIRST 33MM VALVE WAS CINCHED BY THE SCRUB NURSE AND THE STRINGS WERE SNAPPED, AFTER THAT A SECOND 33MM VALVE WAS OPENED AND CINCHED BY THE SENIOR REGISTRAR UPON WHICH THE STRINGS ALSO SNAPPED. A 31MM VALVE WAS THEN OPENED AND IMPLANTED IN THE PATIENT. THE TWO 33MM VALVES WERE NEVER IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25071069 ↗
• MalfunctionMay 4, 2026Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE, THE CINCH STRINGS BROKE ON TWO 33MM MOSAIC MITRAL VALVES. IT WAS REPORTED THAT THE FIRST 33MM VALVE WAS CINCHED BY THE SCRUB NURSE AND THE STRINGS WERE SNAPPED, AFTER THAT A SECOND 33MM VALVE WAS OPENED AND CINCHED BY THE SENIOR REGISTRAR UPON WHICH THE STRINGS ALSO SNAPPED. A 31MM VALVE WAS THEN OPENED AND IMPLANTED IN THE PATIENT. THE TWO 33MM VALVES WERE NEVER IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25070921 ↗
• InjuryApr 22, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT 3 MONTHS POST IMPLANT OF THIS 33 MITRAL BIOPROSTHETIC VALVE, A BIVENTRICULAR DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE BIVENTRICULAR DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY AND INCOMPLETE ATRIOVENTRICULAR BLOCK (AVB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy; Non specific EKG/ECG Changes

  MAUDE report 24952714 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NEW 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 24660088 ↗
• InjuryMar 9, 2026Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR REPLACEMENT WAS MITRAL VALVE ENDOCARDITIS. IT WAS REPORTED THAT A TRANSTHORACIC ECHOCARDIOGRAM (TTE) PERFORMED PRIOR TO EXPLANT NOTED TRACE PARAVALVULAR LEAK WITH MOBILE P2 VEGETATION AND SLIGHTLY ELEVATED MEAN PRESSURE GRADIENT OF 5 - 7MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information; Valvular Insufficiency/ Regurgitation

  MAUDE report 24545089 ↗
• InjuryNov 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 6 MONTHS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NEW 33MM 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

  MAUDE report 23579496 ↗
• InjuryJul 21, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE 33MM MITRAL BIOPROSTHETIC VALVE WAS IMPLANTED IN THE TRICUSPID POSITION. IT WAS ALSO FURTHER REPORTED THAT THE REASON FOR REPLACEMENT WAS ENDOCARDITIS. THE ORGANISM CULTURED WAS UNKNOWN. VEGETATION COULD BE SEEN IN THE RIGHT VENTRICLE. THE PATIENT HAD SYMPTOMS OF SHORTNESS OF BREATH. MEDICATION WAS ADMINISTERED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Endocarditis; Insufficient Information

  MAUDE report 22553015 ↗
• InjuryJul 18, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 33MM MOSAIC MITRAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A DEVICE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22539839 ↗
• DeathJun 24, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 9 DAYS POST IMPLANT OF THIS MOSAIC 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: Cardiogenic Shock; Insufficient Information; Septic Shock

  MAUDE report 22318526 ↗
• InjuryJun 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR IMPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22219618 ↗
• InjuryJun 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 23MM 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 22218935 ↗
• InjuryJun 10, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED WITH A 31MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 22177542 ↗
• InjuryMar 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 33MM MOSAIC MITRAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A DEVICE 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 21502436 ↗
• InjuryDec 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 7 MONTHS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM 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 20894466 ↗
• MalfunctionNov 22, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE CINCH MECHANISM SUTURE BROKE DURING A QUICK HANDLE TURN. IT WAS REPLACED WITH ANOTHER VALVE OF THE SAME MODEL WHICH WAS IMPLANTED WITHOUT ISSUE. IT WAS INDICATED THAT THE CINCH MAY HAVE BEEN TIGHTENED TOO MUCH. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20764482 ↗
• MalfunctionNov 21, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE RATCHETING OF THIS 33MM BIOPROSTHETIC VALVES, THE CINCH SUTURE BROKE. THE VALVE WAS REPLACED WITH A 31MM VALVE OF THE SAME MODEL. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748039 ↗
• InjuryAug 22, 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 INSUFFICIENCY. NO ADDITIONAL ADVERSE P ATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20029235 ↗
• InjuryAug 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, A BI-VENTRICULAR DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR IMPLANT WAS REPORTED AS CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 19973105 ↗
• InjuryApr 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 11 MONTHS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED WITH A 31MM 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 19060311 ↗
• InjuryFeb 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR POST IMPLANT OF THIS 33MM 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 18773017 ↗
• InjuryDec 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIO-VENTRICULAR BLOCK (AVB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 18309490 ↗
• InjuryDec 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 2 MONTHS POST IMPLANT OF THIS 33MM 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 18265015 ↗
• DeathNov 13, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 12 DAYS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, THE PATIENT WAS REPORTED AS DECEASED. THE CAUSE OF DEATH WAS SEPTIC SHOCK. IT WAS STATED THAT DURING THE IMPLANT PROCEDURE THE PATIENT WAS UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS. A INTRA-AORTIC BALLOON PUMP WAS ATTEMPTED TO BE USED, HOWEVER, IT IS INDICATED THAT THIS WAS UNABLE TO BE INSERTED. THE ADMINISTRATION OF INOTROPES WAS THEN INCREASED.

  Patient problems: Septic Shock

  MAUDE report 18121630 ↗
• InjuryOct 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THE REASON FOR REPLACEMENT AS PROSTHETIC MITRAL VALVE ENDOCARDITIS, MILD MITRAL REGURGITATION, PARTIAL SLIDING ON THE MEDIAL ASPECT OF THE SEWING RING, ALONG THE ANNULUS WHICH WAS CONSISTENT WITH MINIMAL DEHISCENCE AND SOME ROCKING MOTION. IT WAS REPORTED THAT THE PATIENT HAD A PRE-EXISTING CONDITION OF STAPHYLOCOCCUS AUREUS BACTEREMIA WHICH MAY HAVE CONTRIBUTED TO THE EVENT. IT WAS STATED THAT THE PATIENT'S INTRAVENOUS (IV) DRUG ABUSE MAY HAVE CONTRIBUTED TO THE EVENT AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 17955689 ↗

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