Melody™ TPV PB1016 (UDI 00643169415850)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169415850), received between May 9, 2017 and Jun 4, 2026 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 10 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONIC VALVE, THE VALVE WAS EXPLANTED FOR AN UNSPECIFIED REASON. SUBSEQUENTLY, A SURGICAL PULMONIC VALVE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 25394881 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 11 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, INFECTIVE ENDOCARDITIS WAS IDENTIFIED. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED AND EXPLANT OF THE TRANSCATHETER PULMONARY VALVE WAS PLANNED AS WELL AS THE IMPLANT OF A NEW TRANSCATHETER PULMONARY VALVE. PER THE PHYSICIAN, THE TRANSCATHETER PULMONARY VALVE CONTRIBUTED TO THE PATIENT'S INFECTIVE ENDOCARDITIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ENDOCARDITIS WAS CONFIRMED, AND VEGETATION WAS PRESENT ON ECHOCARDIOGRAM. IT WAS CLARIFIED THAT THIS TRANSCATHETER VALVE WILL BE REPLACED WITH JUST A SURGICAL PULMONARY VALVE. THERE WERE NO FACTORS THAT WOULD HAVE PREDISPOSED THE PATIENT TO ENDOCARDITIS, AND THE PATIENT DOES NOT HAVE A HISTORY OF ENDOCARDITIS.

  Patient problems: Endocarditis

  MAUDE report 24716461 ↗
• InjuryAug 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY FOUR YEARS EIGHT MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOP ROSTHETIC VALVE, THE VALVE WAS REPLACED DUE TO AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17493162 ↗
• InjuryDec 3, 2021Gradient Increase; Mechanical Problem; Gradient Increase; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY SIX YEARS AND TWO MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, THE VALVE WAS RE-DILATED AS A RESULT OF PULMONARY STENOSIS. VALVE STENOSIS AND MODERATE PULMONARY REGURGITATION (PR) WITH A GRADIENT ACROSS THE VALVE WERE REPORTED. APPROXIMATELY SIX YEARS AND ELEVEN MONTHS FOLLOWING THE VALVE IMPLANT, INCREASED RIGHT VENTRICLE PRESSURES, REPORTED AS 3/4 THE SYSTEMIC PRESSURE, MODERATE PR AND A GRADIENT OF 30 MILLIMETERS OF MERCURY (MMHG) ACROSS THE PULMONARY VALVE WERE REPORTED. A PALMAZ STENT AND NEW MELODY VALVE WERE IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 12927332 ↗
• InjurySep 24, 2020Adverse 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 FIVE YEARS, FIVE MONTHS AND SIXTEEN DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, THE VALVE WAS SURGICALLY EXPLANTED AND REPLACED WITH A MEDTRONIC SURGICAL VALVE. THE REASON FOR EXPLANT AND REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Pulmonary Valve Stenosis

  MAUDE report 10579901 ↗
• InjurySep 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 26 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE THE VALVE WAS EXPLANTED AND A SURGICAL WAS IMPLANTED FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10556442 ↗
• InjuryDec 9, 2019Fracture; Gradient Increase; Fracture; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT FIVE YEARS, FIVE MONTHS, AND SIXTEEN DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, INCREASED SYSTEM RIGHT VENTRICULAR AND PULMONARY ARTERY PRESSURES WERE NOTED. BALLOON DILATION X2 OF THE VALVE WAS REQUIRED DUE TO A VALVE GRADIENT OF 48 MILLIMETERS OF MERCURY (MMHG). VALVE FLUOROSCOPY IDENTIFIED A PROXIMAL STENT FRACTURE AND A NEW MELODY VALVE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9437546 ↗
• InjuryJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8802977 ↗
• MalfunctionFeb 7, 2019Fracture; Gradient Increase; Fracture; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS, TWO MONTHS, TWELVE DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, RIGHT VENTRICLE (RV) PRESSURE WAS GREATER THAN 90MM HG AND THE VALVE GRADIENT WAS GREATER THAN 60MM HG. ANGIOGRAPHY NOTED MULTIPLE STENT FRACTURES WITH SIGNIFICANT OVAL APPEARANCE. IT WAS REPORTED THAT POST-IMPLANT OF THE VALVE, THE GRADIENT WAS 10MM HG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8318904 ↗
• InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT TEN MONTHS AND TWENTY-FOUR DAYS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, INTO A PREVIOUSLY PLACED CONDUIT, THE VALVE AND CONDUIT WERE EXPLANTED AND REPLACED SURGICALLY WITH A MEDTRONIC VALVE. PRIOR TO THE EXPLANT, CARDIAC CATHETERIZATION REVEALED A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) PRESSURE GRADIENT OF 30 MM HG, RVOT STENOSIS AND MODERATE MITRAL REGURGITATION (MR). A DECREASE IN ACTIVITY LEVEL WAS ALSO REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 8150674 ↗
• InjuryAug 14, 2018Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

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

  Patient problems: No Information

  MAUDE report 7782496 ↗
• InjuryAug 6, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT TWO YEARS AND FIVE MONTHS THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, IN THE MITRAL POSITION, THE VALVE WAS REPLACED FOR AN UNKNOWN REASON. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 7754144 ↗
• MalfunctionNov 20, 2017Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 2 MONTHS POST IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, SEVERAL MINOR STENT FRACTURES WERE NOTED IN THE PROXIMAL HALF OF THE STENT. NO TREATMENT WAS GIVEN AND THE DEVICE REMAINED IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7047644 ↗
• MalfunctionMay 9, 2017Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION THAT TWENTY-TWO MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, CHEST XRAY SHOWED FOUR MINOR STENT FRACTURES AT THE ANTERIOR-SUPERIOR PORTION OF THE STENT. THERE WAS NO LOSS OF STENT INTEGRITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6553862 ↗