MOSAIC ULTRA® 305U221 (UDI 00643169594944)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00643169594944), received between Dec 6, 2018 and Dec 2, 2025 — classified as 17 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT 5 YEARS AND 6 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. IT WAS REPORTED THAT AN INTERVENTION IS REQUIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23690863 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE CAUSE OF DEATH AS CARDIOGENIC SHOCK. IT WAS FURTHER REPORTED THAT THE PATIENT ALSO HAD CONTRIBUTING FACTORS SUCH AS LACTIC ACIDOSIS AND SHOCK. IT IS UNKNOWN IF THE PHYSICIAN BELIEVES THE BIOPROSTHETIC VALVE CAUSED OR CONTRIBUTED TO THE PATIENTS DEATH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cardiogenic Shock

  MAUDE report 23567927 ↗
• InjuryMar 18, 2025Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS HEMODYNAMIC INSTABILITY AND PATIENT PROTHESIS MISMATCH. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 5 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21633268 ↗
• MalfunctionFeb 10, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 21MM MOSAIC AORTIC VALVE HAD VALVE STENOSIS. AN ELEVATED GRADIENT WAS ALSO NOTED, AND THIS GRADIENT HAS CONTINUED TO INCREASE OVER THE PAST TWO YEARS. THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21341852 ↗
• MalfunctionJan 9, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION 2 YEARS AND 11 MONTHS POST IMPLANT OF THIS 21 MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21121022 ↗
• MalfunctionSep 16, 2024Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION 7 YEARS AND 5 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE THAT THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. IT WAS MENTIONED THAT CALCIFICATION WAS OBSERVED IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) UNDER THE RIGHT CORONARY CUSP (RCC). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 20223479 ↗
• InjuryMar 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION 4 YEARS AND 7 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 NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY 2 MONTHS LATER, THE PATIENT HAD AN SURGICAL VALVE REPLACEMENT WITH A 21MM BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18865532 ↗
• InjuryDec 4, 2023Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REASON FOR INTERVENTION WAS SEVERE AORTIC REGURGITATION (AR). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 18256517 ↗
• InjuryMay 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS MIXED NATIVE AORTIC VALVE DISEASE DEMONSTRATING AORTIC STENOSIS AND MODERATE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 17011937 ↗
• InjuryMar 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 16634212 ↗
• InjuryNov 16, 2022Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 10 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS PATIENT PROSTHESIS MISMATCH AND AN INCREASED GRADIENT. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 23 DAYS LATER A TRANSCATHETER VALVE WAS I MPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15805526 ↗
• InjurySep 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 3 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 SEVERE AORTIC REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY ONE MONTH LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15504868 ↗
• InjuryJul 4, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 1 MONTH POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED TO BE DUE TO AORTIC STENOSIS AND AORTIC REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY 19 DAYS LATER THE PATIENT SUCCESSFULLY HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS PATIENT-PROSTHESIS MISMATCH AND SEVERE AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 14904104 ↗
• InjuryMar 18, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 10 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM 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 13804085 ↗
• InjuryNov 17, 2021Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 9 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS DUE TO A HYPO ATTENUATED LEAFLET THROMBOSIS. THE PHYSICIAN ATTEMPTED TO TREAT WITH PRESCRIPTION MEDICATION, BUT AN INCREASED GRADIENT REMAINED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12830121 ↗
• InjuryApr 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 6 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. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 11703604 ↗
• InjuryMar 2, 2021Gradient Increase; Inadequacy of Device Shape and/or Size; Gradient Increase; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 8 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE VALVE WAS REPLACED DUE TO PATIENT PROSTHESIS MISMATCH AND INCREASED MEAN GRADIENT (36MMHG). THE AORTIC VALVE AREA WAS REPORTED TO BE 0.72CM². NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11399948 ↗
• InjuryNov 30, 2020Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE OF THIS 21MM BIOPROSTHETIC AORTIC VALVE, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A PARAVALVULAR LEAK. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER VALVE OF THE SAME SIZE AND MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma; Valvular Insufficiency/ Regurgitation

  MAUDE report 10920087 ↗
• InjuryOct 31, 2019Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 1 MONTH POST IMPLANT OF THIS 21MM BIOPROSTHETIC AORTIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM BIOPROSTHETIC VALVE OF A DIFFERENT MODEL FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9260255 ↗
• InjuryDec 6, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY ONE YEAR POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 23MM BIOPROSTHETIC VALVE OF A DIFFERENT MODEL DUE TO PATIENT PROSTHESIS MISMATCH (PPM).  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ONE CORONARY ARTERY BYPASS GRAFT WAS USED DURING THE REDO AORTIC VALVE REPLACEMENT (AVR).

  Patient problems: No Information

  MAUDE report 8139091 ↗

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