MOSAIC® 305C221 (UDI 00643169001756)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169001756), received between Jan 23, 2017 and Apr 28, 2026 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 YEARS AND 3 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 25014485 ↗
• InjuryNov 13, 2025Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 13 YEARS AND 2 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC INSUFFICIENCY AND AORTIC STENOSIS. EVIDENCE OF CALCIFICATION WAS SEEN IN THE RIGHT CORONARY CUSP (RCC), SINO-TUBULAR JUNCTION (STJ) AND PROTRUDING CALCIFICATION IN THE AORTIC ARCH. IT WAS ALSO STATED THAT PALQUE/THROMBUS WITH IRREGULAR LUMINAR BORDERS SEEN IN THE DESCENDING THORACIC AORTA. SUBSEQUENTLY, ON (B)(6) 2025, THE PATIENT SUCCESSFULLY HAD A 23MM TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Calcium Deposits/Calcification; Thrombosis/Thrombus

  MAUDE report 23540541 ↗
• InjuryAug 13, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 11 MONTHS POST IMPLANT OF THIS MOSAIC AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC INSUFFICIENCY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22796215 ↗
• InjuryMar 25, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 4 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS MODERATE AORTIC REGRUGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21689534 ↗
• InjuryJan 29, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT POST IMPLANT OF THIS MOSAIC AORTIC BIOPROSTHETIC VALVE, THE PATIENT WAS BEING EVALUATED FOR A TRANSCATHETER VAL VE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS. SUBSEQUENTLY ONE MONTH LATER, A 23MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21261744 ↗
• InjurySep 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 17805980 ↗
• InjuryMar 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 4 MONTHS POST IMPLANT OF THIS AORTIC 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: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 16589134 ↗
• InjuryJan 27, 2022Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 7 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS AND A GRADIENT OF 36MMHG . IT WAS ALSO REPORTED THAT INCREASED QRS INTERVALS WERE NOTED DURING THE IMPLANT PROCEDURE, BUT NO ACTION WAS TAKEN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 13373801 ↗
• InjuryMar 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT'S MOTHER THAT 6 YEARS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE IMPLANTED IN AN (B)(6) YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE IN THE AORTIC POSITION. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8386809 ↗
• InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS 3 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPLACED WITH A 23MM TRANSCATHETER AORTIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; No Information

  MAUDE report 8352254 ↗
• InjuryJan 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ELEVEN MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, IT WAS REPLACED VALVE-IN-VALVE. NO FAILURE MECHANISM WAS PROVIDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6271922 ↗

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