HarmonyRecalls & reported problems across all models

We found 3 models of Harmony by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 194 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2021 and Sep 24, 2026 — classified as 3 deaths, 122 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (82 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

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

Harmony recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 22, 2026Open, Classified

   Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.

   Z-2624-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Mar 2, 2022Open, Classified

   There is potential for the capsule bond to break during the procedure.

   Z-0927-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Harmony problems

Harmony models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Harmony™ HARMONY-25

  Pulmonary valve prosthesis percutaneously delivered
  3 deaths151 reports
• Harmony™ HARMONY-DCS

  Pulmonary valve prosthesis percutaneously delivered
  2 recalls35 reports
• Harmony™ HARMONY-22

  Pulmonary valve prosthesis percutaneously delivered
  8 reports

Recent Harmony adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Thickening of Material; Intravalvular regurgitation

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 50885865 ↗
• InjuryJul 17, 2026Gradient Increase; Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED THAT 3 YEARS AND 1 MONTH FOLLOWING IMPLANTATION OF A TRANSCATHETER PULMONARY VALVE, THE PATIENT PRESENTED TO THEIR PRIMARY CARE PHYSICIAN AFTER DEVELOPING FEVER, HEADACHE, FATIGUE, AND DIARRHEA. THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC AND GIVEN RETURN PRECAUTIONS. WITH THE PATIENT'S SYMPTOMS NOT RESOLVING, THEY PRESENTED TO THE EMERGENCY DEPARTMENT. DURING THIS EVALUATION, LAB WORK WAS OBTAINED WHICH REFLECTED A WHITE BLOOD CELL COUNT OF 23 × 10³ CELLS PER MICROLITER (× 10³/¿L), A HEMOGLOBIN OF 10.2 GRAMS PER DECILITER (G/DL), A PLATELET COUNT OF 223 THOUSANDS PER MICROLITER (K/¿L), AND A WHITE BLOOD CELL CONCENTRATION OF 93.6% NEUTROPHILS. THE PATIENT WAS ALSO NOTED TO HAVE A FEVER, A TACHYCARDIC RATE, AND BLOOD CULTURES POSITIVE FOR STREPTOCOCCUS SPECIES. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS ALSO OBTAINED, WHICH INDICATED PULMONARY VALVE ENDOCARDITIS, VEGETATIONS ON THE SEPTAL MOST LEAFLET OF THE PULMONARY VALVE, AND A PERIVALVULAR ABSCESS. SUBSEQUENTLY, THE PATIENT WAS ADMINISTERED INTRAVENOUS THERAPY (IV) ANTIBIOTICS AND TRANSFERRED TO A FACILITY THAT COULD PROVIDE A HIGHER LEVEL OF CARE. ONCE TRANSFERRED, AN ECHOCARDIOGRAM WAS OBTAINED, WHICH REVEALED THIC

  Patient problems: Bacterial Infection; Chills; Diarrhea; Endocarditis; Fatigue; Fever; Tachycardia; Thromboembolism; Transvalvular Pressure Gradient Increased

  MAUDE report 25862138 ↗
• InjuryJun 16, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER PULMONARY VALVE IMPLANT PROCEDURE, A PRE-IMPLANT BALLOON VALVULOPLASTY WAS COMPLETED DUE TO A REGION OF NARROWING THAT THE PHYSICIAN BELIEVED NEEDED TO BE ADDRESSED. THE VALVE WAS THEN SUCCESSFULLY IMPLANTED. 5 MONTHS FOLLOWING IMPLANTATION OF A TRANSCATHETER PULMONARY VALVE, THE PATIENT DEVELOPED INFECTIVE ENDOCARDITIS. SUBSEQUENTLY, THE VALVE WAS EXPLANTED, AND A SURGICAL PULMONARY VALVE WAS IMPLANTED.

  Patient problems: Endocarditis

  MAUDE report 25522753 ↗
• InjuryMay 29, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONIC VALVE, AN AVALUS VALVE WAS IMPLANTED FOR AN UNSPECIFIED REASON.

  Patient problems: Insufficient Information

  MAUDE report 25332522 ↗
• InjuryMay 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE COMPLETION OF A TRANSCATHETER PULMONARY VALVE IMPLANT PROCEDURE, AN ACCESS SITE ANEURYSM WAS IDENTIFIED WITHIN THE SAME DAY. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED AND PERCUTANEOUS ANEURYSM EMBOLIZATION WAS CARRIED OUT ONE DAY FOLLOWING THE PROCEDURE. ENDOVASCULAR HEMOSTASIS WAS THEN ACHIEVED. PER THE PHYSICIAN, THE ANEURYSM WAS CAUSED BY A HIGH-LEVEL PUNCTURE. PER THE PHYSICIAN, THERE IS A CAUSAL RELATIONSHIP BETWEEN THE TECHNIQUE AND THE PATIENT COMPLICATION.

  Patient problems: Aneurysm

  MAUDE report 25306473 ↗
• InjuryMay 22, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 4 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PATIENT WAS RE-HOSPITALIZED WITH A FEVER, FATIGUE, BODY ACHES, EPISODES OF DIZZINESS WITH STANDING, VOMITING, DIARRHEA, AND HYPOTENSION. ENDOCARDITIS WAS CONFIRMED, WITH STAPHYLOCOCCI THE ORGANISM THAT WAS CULTURED. THE PATIENT WAS ADMINISTERED CEFTRIAXONE AND VANCOMYCIN TO TREAT THE INFECTION. APPROXIMATELY 27 DAYS FOLLOWING THE INITIAL RE-HOSPITALIZATION, THE VALVE WAS EXPLANTED.

  Patient problems: Diarrhea; Dizziness; Endocarditis; Fatigue; Low Blood Pressure/ Hypotension; Vomiting

  MAUDE report 25255798 ↗
• InjuryMay 18, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONIC VALVE, HEMOPTYSIS, A DECREASE IN SPO2, AND A DECREASE IN BLOOD PRESSURE WERE CONFIRMED DUE TO A RIGHT PULMONARY ARTERY PERFORATION. SUBSEQUENTLY, 4 MILLIMETER (MM) AND 6 MM PLUGS WERE IMPLANTED, AND VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED. SUBSEQUENTLY, THE BLEEDING RESOLVED AND THE PATIENT WAS RETURNED TO THE ROOM.

  Patient problems: Great Vessel Perforation; Hemoptysis; Low Blood Pressure/ Hypotension

  MAUDE report 25209374 ↗
• MalfunctionMay 11, 2026Material Invagination; Structural Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER PULMONIC VALVE, UPON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE INFOLDED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED, AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. A NEW VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE OPENED AND USED. PER THE PHYSICIAN, THE PATIENT'S TORTUOUS ANATOMY CONTRIBUTED TO THE INFOLD. A 30-45 MINUTE PROCEDURAL DELAY OCCURRED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25138850 ↗
• InjuryApr 24, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 3 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, A SECOND TRANSCATHETER PULMONARY VALVE WAS IMPLANTED VALVE-IN-VALVE FOR AN UNSPECIFIED REASON.

  Patient problems: Insufficient Information

  MAUDE report 24981267 ↗
• MalfunctionApr 24, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT FOLLOWING A HARMONY TRANSCATHETER PULMONARY VALVE IMPLANT PROCEDURE, MODERATE TRICUSPID REGURGITATION WAS IDENTIFIED ON AN ECHOCARDIOGRAM AT THE IMPLANT VISIT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 24978847 ↗
• InjuryApr 9, 2026Difficult to Advance; Patient Device Interaction Problem

  IT WAS REPORTED, DURING THE ATTEMPTED IMPLANTATION OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPV), IN A PATIENT WITH TORTUOUS ANATOMY AND A SMALL LEFT PULMONARY ARTERY (LPA) ACUTE ANGLE, THE TORTUROUS ANATOMY POSED PROCEDURAL CHALLENGES FROM THE START OF THE CASE. AFTER PERFORMING SEVERAL ATRIAL LOOP ATTEMPTS TO PLACE THE VALVE IN THE OPTIMAL POSITION, THE IMPLANT TEAM DID NOT FEEL IT WAS SAFE TO CONTINUE WITH THE SAME DELIVERY CATHETER SYSTEM (DCS) AND OPTED TO USE A SECOND DCS. DURING THE ATTEMPT TO PLACE THETPV IN THE OPTIMAL POSITION, THE PATIENT¿S ACUTE LPA ANGLE CONTRIBUTED TO HEMODYNAMIC INSTABILITY. THE SYSTEM WAS SUBSEQUENTLY WITHDRAWN FROM THE PATIENT¿S BODY, AND THE PROCEDURE WAS ABORTED PER THE ANESTHESIOLOGIST¿S RECOMMENDATION. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PRODUCT ISSUE.

  Patient problems: Hemodynamic instability

  MAUDE report 24834927 ↗
• InjuryMar 3, 2026Difficult or Delayed Positioning; Difficult to Open or Close; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER PULMONARY VALVE IMPLANT PROCEDURE, THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO THE PATIENT AND ADVANCED THROUGH THE PATIENT'S ANATOMY. THE VALVE WAS THEN DEPLOYED UP TO ROW 3, WITH THE USE OF A GUIDEWIRE IN THE RIGHT PULMONARY ARTERY POSITION. ANGIOGRAPHY THEN REVEALED VIA THE LATERAL VIEW THAT THE ROW 1 VALVE CROWNS WERE TOO LOW ON THE PULMONARY ARTERY AND THAT THE VALVE ITSELF WAS TILTED. SUBSEQUENTLY, IT WAS ATTEMPTED TO RECAPTURE THE VALVE INTO THE DCS. HOWEVER, THE VALVE WAS NOT ABLE TO BE RECAPTURED INTO THE DCS. IN RESPONSE, THE PHYSICIAN PULLED THE DCS, VALVE, AND NON-MEDTRONIC (GORE) 26 FRENCH (FR) INTRODUCER SHEATH INTO THE PATIENT¿S RIGHT VENTRICLE. WHEN THE ENTIRE SYSTEM WAS PULLED INTO THE RIGHT VENTRICLE, SUSTAINED VENTRICULAR TACHYCARDIA OCCURRED. THIS SUSTAINED VENTRICULAR TACHYCARDIA LASTED FOR 3 TO 4 MINUTES, BUT NO TREATMENT WAS PROVIDED BECAUSE THE PATIENT'S BLOOD PRESSURE REMAINED STABLE. WITH THE VALVE AND DCS INSIDE THE INTRODUCER SHEATH, THE ENTIRE SYSTEM WAS MOVED TO THE INFERIOR VENA CAVA TO UNSURE NO DAMAGE WAS DONE TO THE TRICUSPID VALVE. THE PHYSICIAN WAS THEN ABLE TO FURTHER ALIGN AND PULL THE DCS AN

  Patient problems: Arrhythmia

  MAUDE report 24495665 ↗
• InjuryFeb 24, 2026Incomplete Coaptation; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONIC VALVE, THE VALVE FAILED DUE TO POOR COAPTATION OF THE LEAFLETS. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED PULMONARY REGURGITATION OF UNSPECIFIED SEVERITY AS A RESULT OF THE POOR COAPTATION. THERE WERE NO ADDITIONAL FACTORS THAT CONTRIBUTED TO THE LEAFLET COAPTATION.

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

  MAUDE report 24431473 ↗
• InjuryFeb 19, 2026Difficult or Delayed Positioning; Material Invagination; Structural Problem; Mechanics Altered; Activation Failure; Intravalvular regurgitation

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER PULMONIC VALVE, UPON THE FIRST DEPLOYMENT ATTEMPT, A BEND IN THE VALVE WAS OBSERVED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED INTO THE DELIVERY CATHETER SYSTEM (DCS). UPON THE SECOND DEPLOYMENT ATTEMPT, IT WAS OBSERVED THAT THE VALVE HAD OPENED PROPERLY WITHOUT BENDING. FOLLOWING FULL DEPLOYMENT OF THE VALVE, CONTRAST INJECTION REVEALED SEVERE CENTRAL PULMONARY REGURGITATION. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED THE REGURGITATION, AND ALSO REVEALED THAT ONLY ONE OF THE THREE LEAFLETS WAS MOBILE. SUBSEQUENTLY, A 24 MILLIMETER (MM) NON-MEDTRONIC BALLOON WAS PARTIALLY INFLATED IN THE VALVE IN ORDER TO RELEASE THE LEAFLETS, HOWEVER THE ATTEMPT WAS UNSUCCESSFUL. THEN, A PIGTAIL CATHETER WAS UTILIZED TO ATTEMPT TO RELEASE THE LEAFLETS, BUT WAS ALSO UNSUCCESSFUL. ULTIMATELY, A NON-MEDTRONIC 26 MM VALVE WAS IMPLANTED VALVE-IN-VALVE. PER THE PHYSICIAN, THE ANATOMICAL STRUCTURE OF THE PATIENT'S RIGHT PULMONARY ARTERY CONTRIBUTED TO THE INITIAL BEND OF THE VALVE. IT WAS NOTED THAT A 1 HOUR PROCEDURAL DELAY OCCURRED AS A RESULT. ADDITIONAL INFORMATION WAS RECEIVED THAT AFTER RELEASING ROWS THREE AND FOUR, THEY APPEARE

  Patient problems: Fever; Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 24391174 ↗
• MalfunctionFeb 13, 2026Difficult or Delayed Positioning; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE IMPLANT OF A TRANSCATHETER VALVE, THE RIGHT PULMONARY ARTERY (RPA) WIRE POSITION WAS USED DURING DEPLOYMENT USING A NON-MEDTRONIC GUIDEWIRE. THE "CARROT" WAS LAUNCHED DEEP INTO THE RPA SUB BRANCH. THE DELIVERY CATHETER SYSTEM (DCS) WAS PULLED AND THE VALVE WAS COVERED BACK TOWARDS THE MAIN PULMONARY ARTERY UNTIL THE RADIOGRAPHIC MARKER BAND OF THE DCS WAS NOTED TO "FLOP" OVER FROM THE RPA OSTIUM TO THE MIDDLE OF THE BIFURCATION ROOF. AFTER UNCOVERING ROWS 1-2 OF THE VALVE FRAME, ONE OF THE CROWNS OF THE RIGHT SIDE OF THE VALVE FRAME "SLIPPED" DOWN BELOW THE "ARMPIT" OF THE RPA. ADDITIONALLY, INADVERTENT UNCOVERING OF ROW 3 OCCURRED, AND THE FRAME OUTFLOW RESTED IN A "KINKED" POSITION. SUBSEQUENTLY, THE VALVE WAS RESHEATHED USING A 26 FRENCH NON-MEDTRONIC INTRODUCER SHEATH DUE TO THE LOW AND TILTED POSITION OF THE PATIENT'S ANATOMY. A NEW VALVE AND NEW DCS WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE DEPTH OF IMPLANT CONTRIBUTED TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334411 ↗

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