Melody™ TPV PB1016 (UDI 00643169588189)Recalls & reported problems
Medtronic, Inc. · VALVE PB1016 MELODY TPV US · Class f · Implant
All models of Melody TPV (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Melody transcatheter pulmonary valve is implanted via catheter to replace a heart valve. The 67 reports mostly describe valves implanted valve-in-valve or removed and replaced years later, sometimes because of narrowing (stenosis) or leaking of the valve; a few mention rising pressure gradients and fracture. There are 66 injuries and 1 death. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 67
- Deaths reported
- 1
- Injuries reported
- 66
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00643169588189), received between Feb 1, 2017 and Sep 28, 2026 — classified as 1 death, 66 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (52 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information52
- Adverse Event Without Identified Device or Use Problem12
- Gradient Increase6
- Device Stenosis4
- Inadequacy of Device Shape and/or Size4
- Fracture3
- Intravalvular regurgitation2
- Activation Failure1
Patient problems
- Insufficient Information27
- No Information11
- No Clinical Signs, Symptoms or Conditions10
- No Known Impact Or Consequence To Patient8
- No Consequences Or Impact To Patient3
- Pulmonary Valve Insufficiency/ Regurgitation3
- Pulmonary Valve Stenosis3
- Vascular System (Circulation), Impaired3
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50918982 ↗InjuryJul 14, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONIC VALVE, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE FOR AN UNSPECIFIED REASON.
Patient problems: Insufficient Information
MAUDE report 25815419 ↗InjuryMay 21, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT 10 YEARS AND ONE MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, A SECOND VALVE WAS IMPLANTED V ALVE-IN-VALVE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25247403 ↗InjuryMay 1, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONIC VALVE, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE FOR AN UNSPECIFIED REASON.
Patient problems: Insufficient Information
MAUDE report 25057192 ↗InjuryJan 22, 2026Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Activation Failure; Device Stenosis
IT WAS REPORTED THAT 10 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE FOR AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions; Valvular Stenosis
MAUDE report 24152855 ↗InjuryDec 18, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis
IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER VALVE, A SECOND TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SECOND TRANSCATHETER VALVE WAS IMPLANTED DUE TO PULMONARY STENOSIS. FOLLOWING THE IMPLANT OF THE SECOND VALVE, THE ISSUE RESOLVED.
Patient problems: Insufficient Information; Pulmonary Valve Stenosis
MAUDE report 23840260 ↗InjuryNov 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT APPROXIMATELY 9 YEARS 7 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER VALVE, A SECOND TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 23572782 ↗InjuryOct 16, 2025Gradient Increase; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation
ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY SIX YEARS AND SEVEN MONTHS POST VALVE IMPLANT, MODERATE STENOSIS WAS REPORTED WITH A MEAN GRADIENT OF 30 MMHG. A REPEAT CARDIAC CATHETERIZATION WAS PERFORMED APPROXIMATELY SEVEN YEARS POST IMPLANT. BALLOONING WAS ATTEMPTED, HOWEVER DUE TO THE PROGRESSIVE INSUFFICIENCY, THE VALVE WAS REPLACED. A NEW VALVE WAS SUCCESSFULLY IMPLANTED AND AN ECHOCARDIOGRAM REVEALED A PEAK GRADIENT OF APPROXIMATELY 30 MMHG.
Patient problems: Foreign Body In Patient; Pulmonary Valve Insufficiency/ Regurgitation; Stenosis
MAUDE report 23311007 ↗InjuryJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, A 2ND TRANSCATHETER PULMONARY VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22460734 ↗InjuryMar 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT FOLLOWING A TRANSCATHETER PULMONARY VALVE IMPLANT, A SECOND TRANSCATHETER VALVE WAS IMPLANTED. INCORRECT DEVICE INFORMATION WAS PROVIDED ON THE PATIENT¿S DEVICE IDENTIFICATION CARD. REGISTRATION CORRECTIONS WERE MADE, AND AN UPDATED IDENTIFICATION CARD WAS SENT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21642342 ↗InjuryJan 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT 5 YEARS AND 1 MONTH FOLLOWING IMPLANT OF A TRANSCATHETER PULMONARY VALVE, THE VALVE WAS EXPLANTED FOR AN UNKNOWN REASON. A NEW SURGICAL VALVE WAS SUBSEQUENTLY IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21056478 ↗InjuryOct 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS 2 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20385025 ↗InjurySep 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 7 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, THE VALVE WAS EXPLANTED FOR AN UNSPECIFIED REASON. SUBSEQUENTLY, A NEW VALVE WAS IMPLANTED IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 20190328 ↗InjuryMay 6, 2024Fracture; Intravalvular regurgitation; Fracture; Intravalvular regurgitation
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED DUE TO CALCIFICATION. APPROXIMATELY 5 YEARS AND 10 MONTHS FOLLOWING VALVE IMPLANT, MILD CENTRAL PULMONARY REGURGITATION WAS NOTED IN ADDITION TO A PROXIMAL TYPE I STENT FRACTURE. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pulmonary Valve Insufficiency/ Regurgitation
MAUDE report 19252983 ↗InjuryApr 24, 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 (B449160), THE VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE (F605876). THE REASON FOR EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 19174438 ↗InjuryFeb 9, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO VALVE DISEASE WITH THE TRANSCATHETER [PULMONARY BIOPROSTHETIC VALVE.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 18675517 ↗InjuryFeb 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY FIVE YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, IN A TEN YEARS, EIGHT AND A HALF MONTH OLD PATIENT, A SECOND VALVE WAS IMPLANTED IN THE SAME POSITION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 18661617 ↗InjuryFeb 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 8 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT HAD TO HAVE A REDO-STERNOTOMY. THE VALVE WAS EXPLANTED AND REPLACED. THE NEED FOR A REDO STERNOTOMY WAS NOT ATTRIBUTED TO THE MELODY VALVE, HOWEVER FURTHER DETAILS WERE NOT PROVIDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR VALVE EXPLANT WAS NOT DUE TO PATIENT OUTGROWTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18655592 ↗InjuryFeb 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY THREE YEARS, TEN MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (B893499), THE VALVE WAS EXPLANTED FOR AN UNKNOWN REASON. SUBSEQUENTLY, A NEW VALVE (F040402) WAS IMPLANTED IN THE SAME PULMONARY POSITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 18647316 ↗InjuryJan 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS 4 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, THE VALVE WAS EXPLANTED FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 18606943 ↗InjuryDec 11, 2023Device Stenosis; Device Stenosis
MEDTRONIC RECEIVED INFORMATION THAT SEVEN YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, THE VALVE BECAME STENOTIC OVER TIME AND WAS REPLACED WITH A NEW, LARGER MELODY VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Stenosis
MAUDE report 18299867 ↗InjuryNov 24, 2023Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information
ADDITIONAL INFORMATION WAS RECEIVED THAT, PER THE PHYSICIAN, THE PATIENT HAD AN INCREASING GRADIENT BY ECHOCARDIOGRAM (ECHO) ACROSS THE PATIENT¿S CONDUIT/PULMONARY VALVE. THE PATIENT¿S RIGHT VENTRICLE (RV) PRESSURE HAD INCREASED INTO THE MID-60S, SO THE TEAM DILATED THE CONDUIT AND PLACED A NEW PULMONARY VALVE AND STENT. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY COMPLAINTS OR SYMPTOMS AT THAT TIME. IN ADDITION, THE PATIENT WAS CURRENTLY DOING WELL WITH AN ECHO DEMONSTRATING A SIGNIFICANT DECREASE IN THE PATIENT¿S RV PRESSURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18204473 ↗InjurySep 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT FIVE YEARS, TEN MONTHS, AND SEVENTEEN DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE INTO A PATIENT WITH AN EXISTING MEDTRONIC PULMONARY VALVED CONDUIT, A SECOND TRANSCATHETER PULMONARY VALVE WAS IMPLANTED FOR AN UNKNOWN REASON. NO FURTHER INFORMATION WAS PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 17745520 ↗InjuryAug 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT SEVEN YEARS AND SIX MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, THE VALVE WAS EXPLANTED FOR AN UNKNOWN REASON. SUBSEQUENTLY, A NEW SURGICAL TISSUE VALVE WAS IMPLANTED IN THE PULMONARY POSITION SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 17666113 ↗InjuryAug 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY ONE YEAR AND SEVEN MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, THE PATIENT DEVELOPED SUBAORTIC STENOSIS AND PRESENTED FOR A RESECTION OF THE SUBAORTIC MUSCLE. THE MEDTRONIC VALVE, IMPLANTED IN THE PULMONARY VALVE, WAS SURGICALLY EXPLANTED AT THE SAME TIME AND REPLACED WITH A NON-MEDTRONIC SURGICAL VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17572198 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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