MOSAIC® 305C221 (UDI 00643169594685)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169594685), received between Jul 2, 2018 and Jan 15, 2025 — classified as 3 deaths, 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 4 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THAT A AORTIC VALVE REPLACEMENT (AVR) WAS ALSO PERFORMED DURING THE SAME PROCEDURE FOR SEVERE AORTIC STENOSIS (AS) AND AORTIC REGURGITATION (AR). A 21MM MOSAIC AORTIC VALVE WAS IMPLANTED DURING THE PROCEDURE. IT WAS INDICATED THAT THE PATIENT HAD SEVERE LEFT VENTRICLE DYSFUNCTION AND REQUIRED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND IMPELLA SUPPORT POST OPERATIVELY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21157001 ↗
• InjuryNov 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE TO TREAT SEVERE AORTIC INSUFFICIENCY, IT WAS REPORTED THAT THE PATIENT WAS PLACED ON AN INTRA-AORTIC BALLOON PUMP (IABP) DUE TO CARDIOGENIC SHOCK AND LEFT VENTRICULAR DYSFUNCTION. IT WAS MENTIONED THAT PRIOR TO THE IMPLANT OF THE 21MM AORTIC VALVE, A POSTERIOR ATRIOVENTRICULAR GROOVE DISRUPTION HAD BEEN CREATED WHILE EXPLANTING THE 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 18047312 ↗
• InjuryOct 31, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 3 WEEKS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE AND 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 18037786 ↗
• InjuryJan 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST IMPLANT OF THIS 21MM MITRAL BIOPROSTHETIC VALVE IN A 4 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

  MAUDE report 16215655 ↗
• DeathOct 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS LISTED AS CARDIOGENIC SHOCK AND ACUTE RENAL FAILURE. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Cardiogenic Shock

  MAUDE report 12674634 ↗
• DeathNov 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM A PATIENT'S SPOUSE THAT THE PATIENT DIED DURING THE SURGERY WHERE THIS BIOPROSTHETIC AORTIC VALVE WAS IMPLANTED. IT WAS REPORTED THAT AFTER COMING OFF CARDIOPULMONARY BYPASS, THE PATIENT'S "PRESSURES WERE HIGH" AND THE PATIENT DIED. THERE IS NO ALLEGATION THAT THE AORTIC VALVE ITSELF CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

  Patient problems: Death

  MAUDE report 10781841 ↗
• DeathOct 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS PATIENT DIED DURING THE IMPLANT PROCEDURE OF THIS BIOPROSTHETIC AORTIC VALVE. IT WAS REPORTED THAT THIS WAS A RE-DO STERNOTOMY WITH A CONCOMITANT CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE, AND THE PATIENT WAS ON AN INTRA-AORTIC BALLOON PUMP. THE CAUSE OF DEATH AND ANY POTENTIAL RELATIONSHIP TO THE BIOPROSTHETIC VALVE IS UNKNOWN AT THIS TIME. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

  Patient problems: Death

  MAUDE report 10744019 ↗
• InjurySep 18, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE 21MM AORTIC BIOPROSTHETIC VALVE WAS SEATED AND SECURED INTO THE ANNULUS. THE SURGEON NOTED THAT THE LEFT AND RIGHT CORONARY OSTIA WERE PARTIALLY BLOCKED AND THE VALVE WAS DETERMINED TO BE OVERSIZED. THE VALVE WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A 19MM VALVE OF THE SAME MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Occlusion

  MAUDE report 7885490 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH 19MM VALVE OF THE SAME MODEL. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7654233 ↗

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