MOSAIC ULTRA® 305U221 (UDI 00643169001848)Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 00643169001848), received between Dec 28, 2016 and Sep 11, 2026 — classified as 125 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (79 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 25 most recent of 135 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Device Stenosis

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50734202 ↗
• MalfunctionJun 3, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT 12 YEARS AND 8 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.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 25371424 ↗
• MalfunctionFeb 26, 2026Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE PATIENT'S HYPERTROPHIC CARDIOMYOPATHY HAD MADE IT SEEM THEIR TRANSVALVULAR GRADIENTS WERE ELEVATED. IT WAS FURTHER REPORTED THAT THE AORTIC BIOPROSTHETIC VALVE IS FUNCTIONING WELL. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy; Insufficient Information

  MAUDE report 24455662 ↗
• InjuryFeb 9, 2026Gradient Increase; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT 10 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 NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 24289689 ↗
• MalfunctionJan 28, 2026Gradient Increase; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT 9 YEARS AND 11 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.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 24199949 ↗
• InjuryJan 8, 2026Calcified; Gradient Increase; Inadequacy of Device Shape and/or Size; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 10 YEARS AND 8 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 ELEVATED GRADIENTS OF 25MMHG. THE PATIENT ALSO HAD SYMPTOMS OF SHORTNESS OF BREATH. IT WAS FURTHER REPORTED THAT MULTIPLE ECHOCARDIOGRAMS (ECHO) AND TRANSESOPHAGEAL ECHOCARDIOGRAMS (TEE) DISCOVERED MODERATE TO SEVERE STENOSIS DUE TO POSSIBLE PATIENT PROTHESIS MISMATCH (PPM), CALCIFICATION AND MILD AORTIC REGURGITATION. SUBSEQUENTLY ON JANUARY 05, 2026 THE PATIENT SUCCESSFULLY HAD A 23MM TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification; Dyspnea

  MAUDE report 24004143 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem; Device Stenosis

  IT WAS REPORTED THAT 11 YEARS AND 4 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM AORTIC BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 23955221 ↗
• InjuryNov 10, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR INTERVENTION AS AORTIC STENOSIS (AS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 23508428 ↗
• InjuryNov 6, 2025Calcified; Calcified

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED AN INTERVENTION IS SCHEDULED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23485308 ↗
• InjuryNov 5, 2025Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Gradient Increase; Patient Device Interaction Problem; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE AORTIC STENOSIS WAS SEVERE. IT WAS STATED THAT A MEAN GRADIENT OF 27MMHG WAS NOTED AND THE PATIENT WAS HOSPITALIZED DUE TO HEART FAILURE. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure

  MAUDE report 23476660 ↗
• InjuryOct 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 13 YEARS AND 10 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, A 23MM 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 23401177 ↗
• InjuryOct 15, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR INTERVENTION AS SEVERE AORTIC INSUFFICIENCY (AI). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 23279326 ↗
• InjuryAug 27, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT 13 YEARS AND 3 MONTHS POST IMPLANT OF THIS 21 MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 22902287 ↗
• InjuryAug 19, 2025Device Stenosis; Device Stenosis

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT 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 Stenosis

  MAUDE report 22839727 ↗
• InjuryAug 13, 2025Gradient Increase; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Gradient Increase; Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  ADDITIONAL INFORMATION RECEIVED REPORTED ON (B)(6) 2026, THE PATIENT SUCCESSFULLY HAD A 23MM AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Cardiovascular Dysfunction/Insufficiency; Corneal Pannus; Thrombosis/Thrombus

  MAUDE report 22795582 ↗
• InjuryJul 28, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED SUBSEQUENTLY, 1 MONTH LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 22635712 ↗
• InjuryJul 23, 2025Gradient Increase; Thickening of Material; Device Stenosis; Gradient Increase; Thickening of Material; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 7 MONTHS 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 22577456 ↗
• MalfunctionMay 15, 2025Device Stenosis; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT "THE PATIENT IS TOO HIGH RISK FOR SURGERY OR TRANSCATHETER AORTIC VALVE REPLACEMENT" AND WOULD BE ON PALLIATIVE CARE ONLY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22028553 ↗
• InjuryMay 15, 2025Intravalvular regurgitation; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE AORTIC INSUFFICIENCY WAS SEVERE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22026836 ↗
• MalfunctionMar 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 9 YEARS AND 11 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE VALVE IS NO LONGER FUNCTIONAL. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21661902 ↗
• InjuryMar 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 MONTHS POST IMPLANT OF THIS 21MM AORTIC 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 21561725 ↗
• InjuryFeb 13, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 21MM MOSAIC AORTIC VALVE WAS EXPERIENCING CENTRAL MODERATE AORTIC REGURGITATION. THE TREATMENT PROVIDED WAS A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21372856 ↗
• MalfunctionJan 23, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION APPROXIMATELY 6 YEARS AND 11 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 REPORTED AS SEVERE AORTIC STENOSIS(AS) WITH A AORTIC VALVE MAXIMAL VELOCITY (AV VMAX) OF 4.5MSEC, A MEAN GRADIENT OF 43MMHG AND A AORTIC VALVE AREA OF 0.5CM2, CLASS II SHORTNESS OF BREATH (SOB), MILD AORTIC REGURGITATION (AR) WHICH WERE OBSERVED DURING A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). PATIENT ALSO UNDERWENT A 4DCAT OF THE HEART REVEALING PERSISTENT THICKENING OF THE BASAL PORTIONS OF ALL THREE LEAFLETS. THE HEALTH CARE PROFESSIONAL (HCP) NOTED "GIVEN PERSISTENCE DESPITE ANTICOAGULATION, CONSIDER CHRONIC FINDINGS RELATED TO VALVULAR DEGENERATION VERSUS PERSISTENT THROMBUS" AND "MODERATE LEAFLET RESTRICTION PERSISTS." NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Dyspnea

  MAUDE report 21218227 ↗
• InjuryJan 23, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A MOSAIC AORTIC VALVE EXPERIENCED SEVERE CENTRAL AORTIC REGURGITATION. THE ISSUE WAS ADDRESSED WITH A TRANSCATHETER VALVE-IN-VALVE IMPLANTATION TO REPLACE THE MEDTRONIC VALVE. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21216854 ↗
• MalfunctionJan 21, 2025Gradient Increase; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Gradient Increase; Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 10 MONTHS POST IMPLANT OF THIS 21MM BIOPROSTHETIC AORTIC VALVE, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED AN AORTIC VALVE MEAN GRADIENT OF 34.5MMHG AND A PEAK GRADIENT OF 60.8MMHG. AORTIC VALVE AREA WAS MEASURED TO BE 0.8 CM^2. THE REPORT INDICATED ¿TEE IMAGES SUGGESTING SOME DEGREE OF INGROWTH INTO THE VALVE VERSUS PATIENT PROSTHESIS MISMATCH.¿ AT THE TIME THE PATIENT¿S BODY SURFACE AREA WAS 2.3. SEVEN MONTHS LATER, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED WHICH SHOWED SEVERE AORTIC STENOSIS WITH A PEAK VELOCITY OF 4.3M/S, MEAN GRADIENT OF 37MMHG AND AN AORTIC VALVE AREA OF 0.8SQCM. ADDITIONALLY, IT WAS REPORTED THAT THERE WERE ¿MODERATELY THICKENED CUSPS¿. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED "SEVERAL HEALTH RELATED ISSUES, ONE OF WHICH WAS HEART FAILURE". A COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM WAS PERFORMED AT THIS TIME TO EVALUATE THE PATIENT FOR POTENTIAL TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure

  MAUDE report 21195137 ↗

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