Melody™ TPV PB1018 (UDI 00643169588196)Recalls & reported problems

Summary

The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 00643169588196), received between Jan 17, 2017 and Sep 29, 2026 — classified as 6 deaths, 173 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (121 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 191 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50932383 ↗
• InjuryJul 30, 2026Insufficient Device Problem Information

  It was reported that 8 years and 3 months following implantation of a transcatheter pulmonary valve, an unspecified valve failure occurred and a second transcatheter valve was implanted valve-in-valve.

  Patient problems: Insufficient Information

  MAUDE report 50089409 ↗
• DeathJun 5, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONIC VALVE, THE PATIENT DIED DUE TO AN UNSPECIFIED REASON.

  Patient problems: Insufficient Information

  MAUDE report 25417776 ↗
• InjuryJun 3, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT 9 DAYS FOLLOWING IMPLANTATION OF A TRANSCATHETER PULMONARY VALVE, ATRIO-VENTRICULAR (AV) BLOCK OF UNSPECIFIED DEGREE OCCURRED AND A PERMANENT PACEMAKER WAS IMPLANTED. 2 YEARS AND 6 MONTHS FOLLOWING IMPLANTATION OF THE VALVE, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE FOR AN UNKNOWN REASON.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 25382989 ↗
• InjuryMay 29, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONIC VALVE, A SECOND PULMONARY VALVE WAS IMPLANTED DUE TO AN UNSPECIFIED REASON.

  Patient problems: Insufficient Information

  MAUDE report 25333369 ↗
• DeathMay 11, 2026Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONIC VALVE, THE PATIENT WAS DIAGNOSED WITH SEPSIS AND ENDOCARDITIS. APPROXIMATELY 3 DAYS LATER, THE PATIENT DIED. PER THE PHYSICIAN, COMPLICATIONS RELATED TO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) MAY HAVE CONTRIBUTED TO THE DEATH.

  Patient problems: Endocarditis; Pulmonary Valve Stenosis; Sepsis

  MAUDE report 25143110 ↗
• InjuryMay 7, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 9 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 25116065 ↗
• InjuryApr 9, 2026Activation Failure; Material Split, Cut or Torn; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED TO CLARIFY THAT THE INFLATION PRESSURE WAS 8 ATMOSPHERES (ATM). AS THE VALVE WAS NOT EXPLANTED, THE TYPE OF LEAFLET DAMAGE IS UNKNOWN; HOWEVER, IT WAS SUSPECTED TO BE A TORN LEAFLET.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 24837348 ↗
• InjuryApr 4, 2026Fracture

  IT WAS REPORTED, APPROXIMATELY FIVE YEARS, ONE MONTH FOLLOWING THE IMPLANT OF THIS 18MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPV), THE PATIENT RECEIVED AN X-RAY OF THE CHEST FOR AN UNKNOWN REASON. UPON EVALUATION OF SUBSEQUENT X-RAY IMAGES, A TYPE II STENT FRACTURE WAS OBSERVED IN THE TPV FRAME. NO TREATMENT WAS PERFORMED, BUT A TPV REPLACEMENT PROCEDURE WAS PLANNED PENDING DENTAL CLEARANCE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION WAS RECEIVED. OF NOTE, THE IMPLANT POSITION OF THE TPV WAS IMMEDIATELY POSTERIOR TO THE STERNUM, WHICH COULD INCREASE THE RISK OF TPV STENT FRACTURES OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24786592 ↗
• InjuryApr 1, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 24755708 ↗
• InjuryMar 30, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT 10 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, A SECOND VALVE WAS IMPLANTED VA LVE-IN-VALVE FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE-IN-VALVE (VIV) WAS PERFORMED DUE TO CENTRAL PULMONARY REGURGITATION OF UNSPECIFIED SEVERITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERITY OF THE CENTRAL PULMONARY REGURGITATION WAS MILD.

  Patient problems: Insufficient Information; Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 24733142 ↗
• InjuryMar 17, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 11 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONIC VALVE, THE VALVE WAS INACTIVATED FOR AN UNSPECIFIED REASON. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618538 ↗
• InjuryFeb 17, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED DURING THE VALVE IMPLANT, A PIGTAIL CATHETER WAS ADVANCED OVER THE WIRE TO THE LEFT PULMONARY ARTERY AND ANGIOGRAPHY WAS PERFORMED WHICH REVEALED UNOBSTRUCTED FLOW INTO THE RIGHT PULMONARY ARTERY WITH SEVERE PULMONARY INSUFFICIENCY. INTRACARDIAC ECHOCARDIOGRAM REVEALED THE VALVE LEAFLETS PROLAPSED AND THERE WAS SEVERE INSUFFICIENCY THROUGH MULTIPLE JETS. THEREFORE A SECOND TRANSCATHETER PULMONARY VALVE WAS PREPARED AND IMPLANTED VALVE-IN-VALVE.

  Patient problems: Insufficient Information; Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 24366464 ↗
• InjuryFeb 10, 2026Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONIC VALVE, A SECOND VALVE WAS IMPLANTED DUE TO AN UNSPECIFIED REASON.

  Patient problems: Insufficient Information

  MAUDE report 24307904 ↗
• InjuryJan 29, 2026Fracture; Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 YEAR AND 1 MONTH AFTER THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, RIGHT HEART CATHETERIZATION WAS PERFORMED DUE TO THE PATIENT HAVING MULTIPLE ECHOCARDIOGRAMS IN THE PRECEDING MONTHS THAT INDICATED AN INCREASED RIGHT VENTRICLE TO PULMONARY ARTERY (RV-PA) GRADIENT. DUE TO THE INCREASED RV-PA GRADIENT, THE PATIENT EXPERIENCED HEMODYNAMIC INSTABILITY. DURING THE RIGHT HEART CATHETERIZATION, SEVERAL STENT FRACTURES WERE IDENTIFIED IN THE PATIENT'S PREVIOUSLY IMPLANTED TRANSCATHETER PULMONARY VALVE. SUBSEQUENTLY, THE ATTENDING PHYSICIAN DECIDED TO TREAT THE PATIENT BY FIRST PERFORMING A PRE-IMPLANT BALLOON VALVULOPLASTY DUE TO IT BEING STANDARD FOR THEIR PRACTICE, AND DUE TO THE PATIENT HAVING CALCIFICATION. A SECOND MELODY TRANSCATHETER PULMONARY VALVE WAS THEN IMPLANTED IN THE PREVIOUSLY IMPLANTED VALVE. PER THE PHYSICIAN, THE VALVE CONTRIBUTED TO THE PATIENT'S SYMPTOMS.

  Patient problems: Hemodynamic instability

  MAUDE report 24215857 ↗
• InjuryJan 22, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 7 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, A SECOND VALVE WAS IMPLANTED VAL VE-IN-VALVE FOR AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24153148 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT 6 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, A SECOND VALVE WAS IMPLANTED VAL VE-IN-VALVE FOR AN UNKNOWN REASON.

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

  MAUDE report 24152986 ↗
• InjuryJan 13, 2026Gradient Increase; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A SECOND TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information; Valvular Stenosis

  MAUDE report 24053766 ↗
• InjuryJan 8, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONIC VALVE, A SECOND TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 24007322 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY (B)(4) FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY VALVE, A SECOND TRANSCATHETER PULMONARY VALVE WAS IMPLANTED VALVE-IN-VALVE FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT THE FIRST TRANSCATHETER PULMONARY VALVE WAS REPLACED SURGICALLY APPROXIMATELY FOUR YEARS AND EIGHT MONTHS POST-IMPLANT WITH A 28 MM PULMONARY HOMOGRAFT CONDUIT INCIDENTALLY AT THE TIME OF SURGICAL AORTIC VALVE REPLACEMENT. THE PULMONARY VALVE WAS REPORTED TO BE WORKING WELL AT THAT TIME. THE NON-MEDTRONIC SURGICAL HOMOGRAFT CONDUIT DEVELOPED RAPID STENOSIS AND A NEW MEDTRONIC TRANSCATHETER PULMONARY VALVE WAS PLACED INTO THE CONDUIT ONE YEAR AND FIVE MONTHS LATER.

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

  MAUDE report 23881867 ↗
• InjuryDec 15, 2025Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER VALVE, A SECOND TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE FOR AN UNSPECIFIED REASON.

  Patient problems: Insufficient Information; Transvalvular Pressure Gradient Increased

  MAUDE report 23805128 ↗
• InjuryDec 8, 2025Malposition of Device; Device Dislodged or Dislocated; Intravalvular regurgitation; Malposition of Device; Device Dislodged or Dislocated; Intravalvular regurgitation

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A TRANSCATHETER PULMONARY VALVE, THE VALVE MISSED THE STENOTIC AREA AND DISLODGED TOWARDS THE RIGHT VENTRICLE. SUBSEQUENTLY, MODERATE CENTRAL PULMONARY REGURGITATION WAS OBSERVED. A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE. AFTER IMPLANTATION, MODERATE PULMONARY REGURGITATION WAS IDENTIFIED. PER THE PHYSICIAN, THE DEPTH OF THE IMPLANT CONTRIBUTED TO THE EVENT.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 23742373 ↗
• MalfunctionDec 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A TRANSCATHETER PULMONARY VALVE, THE VALVE MISSED THE STENOTIC AREA AND DISLODGED TOWARDS THE RIGHT VENTRICLE. SUBSEQUENTLY, MODERATE CENTRAL PULMONARY REGURGITATION WAS OBSERVED. A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE. AFTER IMPLANTATION, MODERATE PULMONARY REGURGITATION WAS IDENTIFIED. PER THE PHYSICIAN, THE DEPTH OF THE IMPLANT CONTRIBUTED TO THE EVENT.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 23742249 ↗
• InjuryDec 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 3 YEARS AND 11 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 23740953 ↗
• InjuryDec 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 4 WEEKS AND 2 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 23693183 ↗