MOSAIC® 310C33 (UDI 00643169001572)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00643169001572), received between Dec 28, 2016 and Mar 18, 2026 — classified as 1 death, 35 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID HAVE HEART BLOCKAGE/PRE EXISTING ARRYTHMIAS PRIOR TO THE HEART VALVE TRANSPLANT. IT WAS ALSO REPORTED THAT THE PHYSICIAN DOES NOT BELIEVE THE HEART VALVE OR IMPLANT PROCEDURE CAUSED OR CONTRIBUTED TO THE CONDUCTION DISTURBANCE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 24625846 ↗
• InjuryMar 12, 2026Perivalvular Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 33MM MITRAL BI OPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS REDO WITH POOR ACCESS. IT WAS REPORTED THAT THE INITIAL VALVE WAS IMPLANTED WITH 9 SUTURES, AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TE) SHOWED LEAKS AROUND SUTURED LINES THEREFORE THE VALVE WAS EXPLANTED AND THE ANNULUS WAS DEBRIDED. IT WAS STATED THAT THE NEW 33MM MITRAL BIOPROSTHETIC VALVE WAS IMPLANTED WITH 12 SUTURES. IT WAS FURTHER NOTED THAT THE PATIENT MAY BE TAKEN TO THE CARDIAC CATHETER LAB TO PLUG ANY HOLES/LEAKS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Valvular Insufficiency/ Regurgitation

  MAUDE report 24579162 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 13 YEARS AND 2 MONTHS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED IN THE SAME POSITION 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 24066966 ↗
• InjurySep 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 8 MONTHS POST IMPLANT OF THIS MITRAL BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22937253 ↗
• InjuryJul 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT TRICUSPID VALVE REPLACEMENT PROCEDURE, DURING WHICH A NEW NON-MEDTRONIC TRICUSPID VALVE WAS IMPLANTED AND THE PREVIOUSLY IMPLANTED VALVE WAS EXPLANTED. THE PRIOR VALVE WAS A 33 MM MITRAL BIOPROSTHETIC VALVE, IMPLANTED IN THE TRICUSPID POSITION ON (B)(6) 2020. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22394407 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A 33MM MOSAIC MITRAL VALVE, TWO SUTURES SNAPPED AFTER CINCHING OF THE VALVE WAS STARTED. IT WAS STATED THAT THERE WAS STILL A LARGE GAP BETWEEN THE STENT POSTS AND WERE NOT EVEN AT 45 DEGREES WHEN THE SNAPPING OCCURRED. THE VALVE WAS NEVER IMPLANTED AND WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053365 ↗
• InjuryOct 31, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 DAYS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, A 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 20578714 ↗
• InjurySep 23, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT WHEN THE WAS BEING RINSED FOR IMPLANTATION, THE NURSE NOTICED THE SUTURE WAS BROKEN AND DANGLING. THE VALVE HAD BEEN STORED AT THE FACILITY FOR A FEW MONTHS PRIOR TO THIS EVENT. THE VALVE WAS NEVER ATTEMPTED TO BE CINCHED. IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO IMPLANT VALVE WITHOUT BEING CINCHED, BUT COULDN¿T GET THE STENT POSTS PAST THE PATIENT ANATOMY, THEREFORE A NEW VALVE WAS NEEDED. A DIFFERENT MANUFACTURER'S PRODUCT WAS IMPLANTED, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20287256 ↗
• InjurySep 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 11 MONTHS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED. THE REASON FOR THE ICD WAS REPORTED AS CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 20148355 ↗
• MalfunctionAug 13, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE PRE-OPERATION OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, THE CINCH SUTURE BROKE. IT WAS STATED THAT THE DEVICE HAD BEEN INSPECTED PRIOR TO USE. A DIFFERENT VALVE OF THE SAME MODEL WAS ULTIMATELY USED. IT WAS NOTED THAT THE VALVE WAS SIZED BEFORE SUTURES WERE PLACED, THE RINSE TIME WAS ONLY 30 SECONDS AND WAS PERFORMED WHILE THE SUTURES ARE BEING PLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972942 ↗
• InjuryJul 24, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 4 MONTHS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR IMPLANT WAS REPORTED AS CARDIOMYOPATHY AND SICK SINUS SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy; Non specific EKG/ECG Changes

  MAUDE report 19816133 ↗
• InjuryJun 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 11 DAYS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SECOND DEGREE ATRIO-VENTRICULAR BLOCK (AVB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 19631515 ↗
• InjuryJun 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS POST IMPLANT OF THIS 33MM 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 19582565 ↗
• InjuryJun 12, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 11 MONTHS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, IT WAS REPORTED THAT THE PATIENT HAD HYPOATTENUATED LEAFLET THICKENING (HALT). ANTICOAGULATION MEDICATION WAS ADMINISTERED. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 5 MONTHS LATER, THE PATIENT IS BEING EVALUATED FOR A VALVE IN VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS TRICUSPID STENOSIS. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Stenosis

  MAUDE report 19519352 ↗
• InjuryMay 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 1 MONTH POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, A REPLACEMENT PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIAL ARRHYTHMIAS OF ATRIAL FIBRILLATION, ATRIAL FLUTTER, ATRIAL TACHYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19357535 ↗
• InjuryFeb 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 33MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MODERATE REGURGITATION. IT WAS NOTED THAT THE MITRAL VALVE HAD DEMONSTRATED SEVERE MITRAL ANNULAR DILATION WITH A LARGE FLAIL P3 SEGMENT. IT WAS STATED THAT THE P3 SEGMENT, WHICH WAS FLAIL OF THE POSTERIOR MITRAL LEAFLET, WAS RESUSPENDED THE RING WAS THEN IMPLANTED AND SUTURES WERE ADJUSTED TO MINIMIZE THE DEGREE OF MITRAL INSUFFICIENCY AND A POSTERIOR MEDIAL COMMISSUROPLASTY WAS PERFORMED. IT WAS REPORTED THAT INSPECTION OF THE VALVE WITH SALINE INFUSION DEMONSTRATED CONTINUED ONGOING PROBABLY AT LEAST MODERATE REGURGITATION PRESENT NEAR THE HOOD OF THE P3 PROLAPSED SEGMENT. AN ATTEMPT WAS MADE TO MINIMIZE THE DEGREE OF MITRAL REGURGITATION BY TUCKING THE SEGMENT DOWN TO THE P2 SEGMENT, HOWEVER, THIS WAS UNSUCCESSFUL AND IT WAS DECIDED TO REPLACE THE VALVE. IT WAS REPORTED THAT THE PATIENT RECEIVED ONE BOUT OF DEFIBRILLATION FOL LOWING THE VALVE REPLACEMENT AND THEN RETURNED TO SPONTANEOUS CARDIAC CONTRACTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 18760712 ↗
• InjuryFeb 22, 2024Patient 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 NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 18756733 ↗
• InjuryJan 11, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 10 DAYS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, 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 18491827 ↗
• InjuryDec 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS ENDOCARDITIS AND SEVERE TRICUSPID REGURGITATION AS THE BIOPROSTHETIC VALVE WAS IMPLANTED IN THE TRICUSPID POSITION. IT WAS ALSO REPORTED THAT THE ORGANISM CULTURED WAS ENTEROCOCCUS FAECALIS. IT WAS ALSO REPORTED THAT THERE WAS VEGETATION ON THE VALVE AND THE PATIENT HAD ANOTHER ACTIVE INFECTION OF HEPATITIS C. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 18262683 ↗
• InjuryOct 3, 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 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 17859049 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 DAYS POST IMPLANT OF THIS 33MM 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 16577056 ↗
• InjuryNov 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 10 MONTHS POST IMPLANT OF THIS 33MM TRICUSPID BIOPROSTHETIC VALVE INDICATED FOR THE MITRAL 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: Endocarditis; Insufficient Information

  MAUDE report 15803301 ↗
• InjuryJun 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 1 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: Endocarditis; Insufficient Information; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 14753985 ↗
• InjuryMay 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 8 MONTHS POST IMPLANT OF THIS 33 MM 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 14477576 ↗
• InjuryOct 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 8 MONTHS POST IMPLANT OF THIS 33MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12674036 ↗

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