Melody™ TPV PB1018 (UDI 00643169415874)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00643169415874), received between Feb 10, 2017 and Apr 16, 2025 — classified as 28 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 reports).

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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2025Fluid/Blood Leak; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Fluid/Blood Leak; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE TYPE OF PULMONARY REGURGITATION WAS CENTRAL, AND THE SEVERITY WAS SEVERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pulmonary Valve Insufficiency/ Regurgitation; Stenosis; Valvular Insufficiency/ Regurgitation

  MAUDE report 21848735 ↗
• InjurySep 12, 2024Fracture; Intravalvular regurgitation; Fracture; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, SEVERE CENTRAL PULMONARY REGURGITATION, AND A STENT FRACTURE WERE OBSERVED. SUBSEQUENTLY, A NEW PULMONARY VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 20202406 ↗
• InjuryAug 28, 2024Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation; Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE IN A PATIENT WITH DOCUMENTED TRANSIENT HEART BLOCK ON AMBULATORY RHYTHM MONITORING, AN ELECTROCARDIOGRAM TAKEN ON THE SAME DAY AS THE PROCEDURE REVEALED A WENCKEBACH CONDUCTION WITH SUBSEQUENT VARIABLE ATRIO-VENTRICULAR BLOCK, INCOMPLETE RIGHT BUNDLE BRANCH BLOCK, AND AN OVERALL VENTRICULAR RATE IN THE 40S THAT RESOLVED SPONTANEOUSLY. AN ECHOCARDIOGRAM REVEALED AN EJECTION FRACTION OF 50-55%, A MEAN GRADIENT OF 8.6 MM HG, A PEAK VELOCITY OF 3.4 M/S, PARAVALVULAR LEAK, TRACE MITRAL REGURGITATION, AND TRACE AORTIC REGURGITATION. THE FOLLOWING DAY, A TRANSVENOUS DUAL CHAMBER PERMANENT PACEMAKER WAS IMPLANTED DUE TO THE SYMPTOMATIC BRADYCARDIA AND AMBULATORY HEART RHYTHM MONITOR FINDINGS. PER THE PHYSICIAN, THE HEART BLOCK WAS NOT CONSIDERED A COMPLICATION OF THE VALVE IMPLANT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Bradycardia; Mitral Valve Insufficiency/ Regurgitation; Non specific EKG/ECG Changes

  MAUDE report 20086861 ↗
• InjuryMar 12, 2024Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS 7 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT DEVELOPED ENDOCARDITIS. THE ENDOCARDITIS WAS MEDICALLY MANAGED. A YEAR LATER, THE PATIENT PRESENTED WITH MIXED STENOSIS AND REGURGITATION. AN RIGHT PULMONARY ARTERY ANGIOPLASTY WAS PERFORMED USING A 20 MM NON-MEDTRONIC ATLAS GOLD BALLOON. A SECOND TRANSCATHETER MELODY VALVE WAS IMPLANTED WITHIN THE EXISTING STENTS/MELODY VALVE THROUGH THE RIGHT FEMORAL ARTERY. A CP COVERED STENT WAS IMPLANTED. ALL STENTS AND THE REPLACEMENT MELODY VALVE WERE POST DILATED USING A 22 NON-MEDTRONIC ATLAS GOLD BALLOON TO 6 ATM. THE FINAL RESULT WAS A 2 MMHG PEAK GRADIENT ACROSS THE CONDUIT. NO COMPLICATIONS WERE REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; No Clinical Signs, Symptoms or Conditions; Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 18886021 ↗
• InjuryJan 31, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY EIGHT YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, A SECOND VALVE WAS IMPLANTED IN THE SAME POSITION FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18619003 ↗
• InjuryAug 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT EIGHT YEARS, EIGHT MONTHS AND SEVEN DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, A SECOND TRANSCATHETER PULMONARY VALVE WAS IMPLANTED VALVE-IN-VALVE IN THE PULMONARY POSITION SUCCESSFULLY. THE REASON FOR THE TWO VALVES WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17487978 ↗
• InjuryJul 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY EIGHT YEARS, NINE MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, THE VALVE WAS EXPLANTED AND REPLACED FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17302094 ↗
• InjuryJan 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT EIGHT YEARS, ONE MONTH, AND FOURTEEN DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE IN THE PULMONARY POSITION FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16130702 ↗
• InjuryDec 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 2 YEARS 7 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE A NEW TRANSCATHETER PULMONARY VALVE WAS IMPLANTED. THE REASON FOR THE NEW VALVE WAS NOT PROVIDED. FOLLOW-UP WAS CONDUCTED TO OBTAIN FURTHER EVENT DETAILS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15979008 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS, 7 MONTHS AND 17 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, A SECOND TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13112503 ↗
• InjurySep 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM PATIENT REGISTRATION SERVICES THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV), FOR AN UNKNOWN REASON, A SECOND TPBV WAS IMPLANTED IN THE SAME POSITION ON THE SAME DAY. NO FURTHER DETAILS NOR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12493291 ↗
• InjuryJan 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY SIX YEARS AND TWO AND A HALF MONTHS AFTER THE IMPLANT OF THIS 18MM TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 26MM BIOPROSTHETIC SURGICAL VALVE. THE REASON FOR THE EXPLANT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11150977 ↗
• InjuryDec 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT SIX YEARS, ONE MONTH, AND TWO DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 10995529 ↗
• InjuryJan 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOUR YEARS, NINE MONTHS AND FOURTEEN DAYS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, A SECOND VALVE WAS IMPLANTED FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9621591 ↗
• InjuryDec 12, 2019Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY FIVE YEARS AND THREE MONTHS FOLLOWING THE IMPLANT OF THIS PULMONARY TRANSCATHETER BIOPROSTHETIC VALVE, A NEW VALVE WAS IMPLANTED IN THE SAME POSITION FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient; No Information

  MAUDE report 9458103 ↗
• InjuryApr 15, 2019Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY THREE YEARS AND EIGHT MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, A SECOND TRANSCATHETER VALVE WAS IMPLANTED FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515112 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY THREE YEARS, ELEVEN MONTHS, THREE DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV), A SECOND TPBV WAS IMPLANTED FOR AN UNKNOWN REASON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8361972 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY THREE YEARS AND NINE MONTHS AFTER THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, THE VALVE WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficiency, Valvular; No Information; Valvular Stenosis

  MAUDE report 8218694 ↗
• InjuryOct 31, 2018Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY THREE YEARS AND EIGHT MONTHS AFTER IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV), A SECOND TPBV WAS IMPLANTED, VALVE-IN-VALVE DUE TO MODERATE TO SEVERE RIGHT VENTRICLE (RV) DILATION WITH DEPRESSED SYSTOLIC FUNCTION AND INCREASED RV PRESSURE AND A MEAN PULMONARY VALVE GRADIENT OF 44 MM HG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8024809 ↗
• InjuryOct 16, 2018Gradient Increase; Naturally Worn; Gradient Increase; Naturally Worn

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY FOUR YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, UPON FOLLOW UP VISIT, ACUTE HIGH GRADIENT ACROSS THE VALVE WAS REPORTED. THE PATIENT WAS ADMITTED AND ENDOCARDITIS WAS DIAGNOSED AFTER STAPHYLOCOCCUS WAS CULTURED. THE VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL BIOPROSTHETIC VALVE. INTRAOPERATIVELY, IT WAS NOTED THAT THE VALVE HAD "ERODED" THROUGH THE CONDUIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Corneal Pannus; Endocarditis

  MAUDE report 7971436 ↗
• InjurySep 5, 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 APPROXIMATELY FOUR YEARS AND ONE MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIO PROSTHETIC VALVE, A SECOND VALVE WAS IMPLANTED FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7848724 ↗
• InjuryAug 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY FOUR YEARS AFTER THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, SEVERE STENOSIS OF THE STENT AND PROXIMAL PORTION OF THE MELODY VALVE WAS NOTED WHICH RESULTED IN SEVERE RIGHT VENTRICLE (RV) HYPERTENSION. STENTING OF THE DISTAL CONDUIT AND VALVE WAS PERFORMED. A SECOND VALVE WAS IMPLANTED, VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: High Blood Pressure/ Hypertension; Stenosis

  MAUDE report 7784189 ↗
• InjuryJun 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY THREE YEARS AND THREE MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, A SECOND TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE WAS IMPLANTED FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7648394 ↗
• InjuryApr 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT ONE MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV), THE PATIENT WAS DIAGNOSED WITH ENDOCARDITIS AND ANTIBIOTICS WERE ADMINISTERED. THE INFECTIVE ORGANISM WAS VIRIDANS STREPTOCOCCAL AND RESULTED IN TRIVIAL STENOSIS AND MILD REGURGITATION. THREE YEARS FOLLOWING THE IMPLANT OF THE VALVE, THE PATIENT PRESENTED WITH A FEVER. ENDOCARDITIS WAS SUSPECTED, BUT NOT CONFIRMED. FOUR BLOOD CULTURE WERE NEGATIVE; HOWEVER, ANTIBIOTICS WERE PRESCRIBED. MILD PULMONARY REGURGITATION WAS NOTES BUT HAD NOT WORSENED SINCE THE PREVIOUS ECHOCARDIOGRAM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Pulmonary Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 7397824 ↗
• InjuryJul 28, 2017Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION THAT THIRTY TWO MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV), MULTIPLE STENT FRACTURES WERE NOTED DESPITE A PRE-STENT. THE PATIENT PRESENTED WITH FEVER AND BACTERIAL INFECTION. INITIAL BLOOD CULTURES GREW GPC ID OF GRANULICATELLA ADIACENS. THE VALVE WAS EXPLANTED AND REPLACED WITH A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) CONDUIT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Congenital Defect/Deformity; Corneal Pannus; Stenosis; Unspecified Infection

  MAUDE report 6749956 ↗