MELODY® PB1018Recalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 00613994663962), received between May 27, 2014 and Jul 17, 2026 — classified as 154 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (96 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 159 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 11 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONIC VALVE, THE VALVE WAS EXPLANTED DUE TO AN UNSPECIFIED REASON. SUBSEQUENTLY, A NON-MEDTRONIC VALVE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 25858974 ↗
• InjuryMar 9, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 14 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONIC VALVE, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE FOR AN UNSPECIFIED REASON.

  Patient problems: Foreign Body In Patient; Stenosis

  MAUDE report 24546281 ↗
• InjuryFeb 24, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 11 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, A SECOND VALVE WAS IMPLANTED VA LVE-IN-VALVE FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 24438282 ↗
• InjuryFeb 10, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT 12 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, A SECOND VALVE WAS IMPLANTED VA LVE-IN-VALVE FOR AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pulmonary Valve Stenosis

  MAUDE report 24305758 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR A LOW EJECTION FRACTION AND DYSSYNCHRONY.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24305247 ↗
• InjuryJan 15, 2026Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED WHICH CLARIFIED THAT THE TPV WAS SURGICALLY EXPLANTED AND REPLACED WITH A NON-MEDTRONIC CONDUIT AN UNSPECIFIED TIME FOLLOWING THE IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 24081328 ↗
• InjuryJan 13, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 13 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY VALVE IN A PREVIOUSLY IMPLANTED SURGICAL PULMONARY VALVE, THE TRANSCATHETER VALVE WAS EXPLANTED FOR AN UNKNOWN REASON. SUBSEQUENTLY, A SURGICAL TISSUE VALVE WAS IMPLANTED IN THE PULMONARY POSITION.

  Patient problems: Insufficient Information

  MAUDE report 24056124 ↗
• InjuryDec 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 14 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A SECOND T RANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE FOR AN UNSPECIFIED REASON.

  Patient problems: Insufficient Information

  MAUDE report 23831850 ↗
• InjuryNov 24, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 12 YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A SECOND TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO AN UNKNOWN REASON.

  Patient problems: Insufficient Information; Valvular Stenosis

  MAUDE report 23638058 ↗
• InjuryOct 21, 2025Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 11 YEARS 5 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY VALVE, A SECOND TRANSCATHETER PULMONARY VALVE WAS IMPLANTED VALVE-IN-VALVE FOR AN UNKNOWN REASON.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 23350946 ↗
• InjurySep 18, 2025Inadequacy of Device Shape and/or Size; Device Stenosis; Intravalvular regurgitation; Inadequacy of Device Shape and/or Size; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY ELEVEN YEARS AND SIX MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, SEVERE CENTRAL PULMONARY REGURGITATION AND STENOSIS WAS OBSERVED. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE. PER THE PHYSICIAN, THE VALVE WAS REPLACED DUE TO NORMAL SOMATIC OUTGROWTH AND THE VALVE EXPERIENCING NORMAL VALVE DETERIORATION.

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

  MAUDE report 23084985 ↗
• InjuryJul 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 14 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY VALVE, A SECOND TRANSCATHETER PULMONARY VALVE WAS IMPLANTED DUE TO AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 22679891 ↗
• InjuryMay 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 12 YEARS AND 1 MONTH AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS E XPLANTED FOR AN UNSPECIFIED REASON. TWO SURGICAL VALVES WERE SUBSEQUENTLY IMPLANTED IN THE PATIENT IN THE TRICUSPID AND MITRAL POSITIONS.

  Patient problems: Insufficient Information

  MAUDE report 22019939 ↗
• InjuryFeb 21, 2025Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Device Stenosis; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 11 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, THE PATIENT WAS HOSPITALIZED WITH FEVERS. DURING THE HOSPITALIZATION, OBSTRUCTION AND VEGETATION OF THE PULMONARY VALVE WAS REVEALED IN ADDITION TO SEPTIC EMBOLI TO THE LUNGS AND SPLEEN. AN ACUTE KIDNEY INJURY WAS ALSO NOTED. BLOOD CULTURES WERE POSITIVE AND CONCERNING FOR METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS ENDOCARDITIS. THE PATIENT SYMPTOMATICALLY IMPROVED AND WAS DISCHARGED ON ANTIBIOTICS APPROXIMATELY 12 DAYS LATER. THE FOLLOWING DAY, THE PATIENT DEVELOPED SHORTNESS OF BREATH, RIGORS WITHOUT FEVER, AND NOTED RAPID WEIGHT GAIN OF 10 POUNDS OVER 48 HOURS. THE PATIENT ALSO NOTED EXPERIENCING PALPITATIONS AND OCCASIONAL CHEST PAIN OVER THE PREVIOUS DAY. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT WHERE THEY WERE PLACED ON A 2 LITER NASAL CANNULA AND GIVEN 1 DOSE OF DIURETIC MEDICATION BEFORE BEING TRANSFERRED TO THE PEDIATRIC INTENSIVE CARE UNIT (PICU). THE PATIENT CONTINUED TO EXPERIENCE INTERMITTENT CHEST PAIN, WITH EPISODES LASTING 15 MINUTES AT A TIME. BRONCHODILATORS AND NARCOTIC ANALGESICS WERE ADMINISTERED FOR THE CHEST PAIN

  Patient problems: Angina; Arrhythmia; Cardiogenic Shock; Dyspnea; Endocarditis; Fever; Pulmonary Embolism; Tachycardia; Unspecified Heart Problem; Weight Changes

  MAUDE report 21434165 ↗
• InjuryJan 24, 2025Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 10 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, A PRE-IMPLANT BALLOON VALVULOPLASTY WAS PERFORMED AS A STANDARD PROCEDURE FOR THE IMPLANTING PHYSICIAN AND A SECOND PULMONARY VALVE WAS SUBSEQUENTLY IMPLANTED IN THE PATIENT.

  Patient problems: Unspecified Tissue Injury; Valvular Insufficiency/ Regurgitation

  MAUDE report 21231561 ↗
• InjuryJan 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 10 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT RECEIVED ANOTHER PULMONARY TRANSCATHETER VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219601 ↗
• InjuryNov 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 13 YEARS AND 6 MONTHS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, A SECOND VALVE WAS IMPLANTED IN THE SAME POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20749410 ↗
• InjuryNov 1, 2024Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS 4 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A TYPE ONE STENT FRACTURE WAS OBSERVED. AS A STANDARD PRACTICE FOR THE IMPLANTING PHYSICIAN, IT WAS DECIDED TO REPLACE THE VALVE WITH A NEW VALVE AND A VALVE-IN-VALVE IMPLANT WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20593866 ↗
• InjuryNov 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 10 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, A SECOND VALVE WAS IMPLANTED IN THE SAME POSITION FOR AN UNSPECIFIED REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588372 ↗
• InjuryOct 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 1 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, THE VALVE WAS EXPLANTED FOR AN UNSPECIFIED REASON AND A NEW SURGICAL VALVE WAS IMPLANTED IN THE SAME POSITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20522879 ↗
• InjurySep 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS 4 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE INSIDE A PREVIOUSLY IMPLANTED SURGICAL VALVE, THE VALVE WAS EXPLANTED DUE TO AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20337961 ↗
• InjurySep 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  CORRECTED INFORMATION WAS RECEIVED THAT THE MELODY VALVE WAS EXPLANTED APPROXIMATELY 10 YEARS AFTER IMPLANT DUE TO SOMATIC GROWTH. A NON-MEDTRONIC VALVE WAS THEN PLACED WHICH FAILED, AND THE SECOND MELODY WAS IMPLANTED AS A REPLACEMENT FOR THE NON-MEDTRONIC VALVE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291888 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 20291235 ↗
• InjuryAug 5, 2024Degraded; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Device Stenosis; Degraded; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO STENOSIS, UNSPECIFIED VALVE DYSFUNCTION, AND OUTGROWTH. PER THE PHYSICIAN, THE SECOND VALVE RESOLVED THE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stenosis

  MAUDE report 19911698 ↗
• InjuryJul 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, THE VALVE WAS EXPLANTED AND A HANCOCK VALVE WAS IMPLANTED IN THE SAME LOCATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19678763 ↗