Melody TPVRecalls & reported problems across all models
Medtronic, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 300
- Deaths reported
- 7
- Injuries reported
- 278
- Recalls
- 0
We found 4 models of Melody TPV by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 300 adverse event reports in the FDA's MAUDE database, received between Jan 17, 2017 and Sep 29, 2026 — classified as 7 deaths, 278 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (195 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Melody TPV problems
Device problems
- Insufficient Device Problem Information195
- Adverse Event Without Identified Device or Use Problem51
- Fracture31
- Gradient Increase29
- Patient Device Interaction Problem21
- Device Stenosis18
- Intravalvular regurgitation17
- Inadequacy of Device Shape and/or Size16
Patient problems
- Insufficient Information114
- No Information41
- No Known Impact Or Consequence To Patient41
- No Clinical Signs, Symptoms or Conditions40
- Pulmonary Valve Stenosis24
- Pulmonary Valve Insufficiency/ Regurgitation16
- Endocarditis13
- Stenosis13
Melody TPV models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Melody™ TPV PB1018Pulmonary valve prosthesis percutaneously delivered6 deaths191 reports
- Melody™ TPV PB1016Pulmonary valve prosthesis percutaneously delivered1 death67 reports
- Melody™ TPV PB1018Pulmonary valve prosthesis percutaneously delivered28 reports
- Melody™ TPV PB1016Pulmonary valve prosthesis percutaneously delivered14 reports
Recent Melody TPV adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50932383 ↗InjurySep 28, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50918982 ↗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 ↗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 ↗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 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other Medtronic, Inc. products
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- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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