Harmony™ HARMONY-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 00763000338992), received between Aug 10, 2021 and Sep 24, 2026 — classified as 3 deaths, 106 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (72 reports).

2 other recalls cover devices cleared under the same FDA submission (P200046); they may or may not involve this specific model.

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 151 reports, 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 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 ↗
• 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 ↗
• 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, 2026Structural Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT A NOSE CONE SEPARATION WAS NOT NOTED DURING THE IMPLANT PROCEDURE AND THAT THE ENTIRE DELIVERY CATHETER SYSTEM (DCS) WAS INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334372 ↗
• InjuryFeb 11, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT 2 DAYS FOLLOWING THE OBSERVATION OF THE ANEURYSM, THE PATIENT HAD SURGICAL INTERVENTION. A 32 MILLIMETER (MM) ATRIAL SEPTAL OCCLUDER WAS PLACED ACROSS THE OPENING OF THE ANEURYSM.

  Patient problems: Aneurysm

  MAUDE report 24318231 ↗
• MalfunctionJan 21, 2026Gradient Increase; Structural Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEPTH OF IMPLANT WAS INTENDED. THE PHYSICIAN WANTED TO HAVE THE VALVE FRAME PULLED INTO A MORE ANNULAR POSITION BY HAVING ROWS 5-6 PROXIMAL TO THE NATIVE ANNULUS. THE VALVE WAS CONFORMING TO THE PATIENT'S ANATOMY. PER THE PHYSICIAN, IT WAS UNKNOWN WHAT CAUSED THE VALVE TO FLIP UPWARDS POINTING TOWARDS THE DISTAL PULMONARY ARTERY. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT'S NATIVE PULMONARY VALVE ANNULUS WAS NARROW, MEASURING 13-17MM IN DIAMETER AT MINIMUM WHICH WAS SUSPECTED TO BE A CONTRIBUTING FACTOR TO THE FINAL RESULT.

  Patient problems: Transvalvular Pressure Gradient Increased

  MAUDE report 24134023 ↗
• MalfunctionJan 21, 2026Structural Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, A CARDIAC MAGNETIC RESONANCE IMAGING REVEALED THE DISTAL PORTION OF THE VALVE WAS PROTRUDING FROM THE PULMONARY ARTERY WALL. THE PROXIMAL EDGE OF THE VALVE STENT WAS IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) POSTERIORLY AND NEAR THE PULMONARY VALVE SINUS ANTERIORLY. THE CONTOUR OF THE ANTERIOR ASPECT OF THE RVOT BOWED OUT AT THE SINUS COMPARED TO THE RIGHT VENTRICULAR WALL AND THE CENTRAL PORTION OF THE STENT. THE DISTAL PORTION OF THE VALVE STENT PROTRUDED FROM THE ANTERIOR WALL OF THE RIGHT PULMONARY ARTERY INTO THE LUMEN OF THE PROXIMAL RIGHT PULMONARY ARTERY. THERE WAS NO EVIDENCE OF FLOW OBSTRUCTION OR STENT FRACTURE. IT WAS ALSO NOTED THAT THESE RESULTS WERE SIMILAR IN APPEARANCE TO THE PRIOR STUDY PERFORMED APPROXIMATELY SIX MONTHS AFTER THE VALVE IMPLANT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132987 ↗
• DeathJan 5, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, NEITHER THE VALVE NOR THE DELIVERY CATHETER SYSTEM CAUSED OR CONTRIBUTED TO THE RIGHT LUNG PERFORATION OR DEATH.

  Patient problems: Cardiac Arrest

  MAUDE report 23956938 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Device Stenosis; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, THE PATIENT DEVELOPED ENDOCARDITIS FROM STAPHYLOCOCCI. STENOSIS OF THE VALVE WAS ALSO OBSERVED. THE PATIENT WAS SCHEDULED FOR A REPLACEMENT OF THE VALVE WITH A NON-MEDTRONIC VALVE APPROXIMATELY 3 WEEKS FOLLOWING THE ONSET OF THE ENDOCARDITIS AND VALVE STENOSIS.

  Patient problems: Endocarditis; Pulmonary Valve Stenosis

  MAUDE report 23871298 ↗
• MalfunctionDec 15, 2025Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation; Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED APPROXIMATELY EIGHT AND A HALF MONTHS FOLLOWING THE IMPLANT OF THIS 25MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, AT THE SIX-MONTH POST-OPERATIVE FOLLOW-UP APPOINTMENT A COMPUTED TOMOGRAPHY WAS PERFORMED. RESULTS SHOWED MODERATE PARAVALVULAR LEAK WITH GRADE II HYPOATTENUATED LEAFLET THICKENING (HALT) OF THE POSTERIOR-FACING LEAFLET WITH VERY MILD REDUCED LEAFLET MOTION (RELM), INDICATING HYPOATTENUATION AFFECTING MOTION (HAM) AND GRADE I HALT OF THE RIGHT-ANTERIOR FACING LEAFLET WITH NO RELM. NO COMPLICATIONS AND NO TREATMENT WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT TO REPORT FATIGUE AND OCCASIONAL PALPITATIONS WERE EXPERIENCED AS A RESULT OF THE PVL, HALT, RELM, AND HAM. THE PULMONARY VALVE GRADIENTS INCREASED FROM PEAK 23MM HG/MEAN 12MM HG WITHIN ONE MONTH POST-IMPLANT TO A PEAK 47MM HG/MEAN 25MM HG FIVE MONTHS LATER IN THE SETTING OF SIGNIFICANT ANEMIA DUE TO UTERINE BLEEDING. THE PATIENT WAS FOUND TO HAVE ACUTE ANEMIA WITH A HGB OF 5.4 G/DL ON ROUTINE TESTING. THE PATIENT WAS REFERRED TO THE EMERGENCY DEPARTMENT (ED) FOR EVALUATION. UPON FURTHER ASSESSMENT, THE ANEMIA FOUND TO BE DUE TO MENORRHAGIA IN THE

  Patient problems: Anemia; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fatigue; Menorrhagia; No Clinical Signs, Symptoms or Conditions; Pulmonary Valve Insufficiency/ Regurgitation; Thrombosis/Thrombus

  MAUDE report 23803927 ↗
• InjuryDec 12, 2025Mechanics Altered; Thickening of Material; Mechanics Altered; Thickening of Material

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COMPUTED TOMOGRAPHY (CT) PERFORMED ALSO NOTED PATCHY AREAS OF GRADE 1 (25%) HYPERATTENUATED LEAFLET THICKENING (HALT) INVOLVING THE ANTERIOR-RIGHT AND ANTERIOR-FACING LEAFLETS WITH NO SIGNIFICANT REDUCED LEAFLET MOTION (RELM). PANNUS AND PARAVALVULAR LEAK (PVL) WERE ABSENT.

  Patient problems: Insufficient Information

  MAUDE report 23789323 ↗
• MalfunctionNov 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS FOLLOWING THE TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE IMPLANT, CINE FLUOROSCOPY IDENTIFIED A TYPE I STENT FRACTURE WITHOUT THE LOSS OF STENT INTEGRITY. THE STENT FRACTURE WAS REPORTED HEMODYNAMICALLY INSIGNIFICANT. TREATMENT WAS NOT REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593190 ↗
• MalfunctionNov 4, 2025Fracture; Mechanics Altered; Intravalvular regurgitation; Fracture; Mechanics Altered; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE MEAN RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) GRADIENT AT THE IMPLANT DISCHARGE MEASURED 17 MILLIMETERS OF MERCURY (MM HG).

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23469237 ↗
• MalfunctionOct 22, 2025Gradient Increase; Intravalvular regurgitation; Gradient Increase; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, MILD CENTRAL PULMONARY REGURGITATION AND A MILD MEAN GRADIENT WERE OBSERVED. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ANTICOAGULATION AND A NONSTEROIDAL ANTI-INFLAMMATORY DRUG. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation; Transvalvular Pressure Gradient Increased

  MAUDE report 23359635 ↗
• MalfunctionOct 15, 2025Particulates; Contamination /Decontamination Problem; Particulates; Contamination /Decontamination Problem

  IT WAS REPORTED THAT UPON OPENING THE PACKAGING OF A TRANSCATHETER VALVE, A BLACK PARTICULATE WAS DETECTED FLOATING IN THE VALVE JAR. SUBSEQUENTLY, THE VALVE WAS NOT USED, AND A NEW VALVE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303328 ↗
• InjurySep 5, 2025No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF THE TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, DURING THE FIRST POSTOPERATIVE NIGHT, RUNS OF NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) WERE OBSERVED. TREATMENT WAS NOT REPORTED. HOWEVER, HOSPITALIZATION WAS REQUIRED. APPROXIMATELY 2 MONTHS FOLLOWING IMPLANT THE NSVT WAS RESOLVED. THE PHYSICIAN INDICATED THE NSVT WAS CAUSALLY RELATED TO THE DELIVERY CATHETER SYSTEM (DCS), VALVE, AND IMPLANT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tachycardia

  MAUDE report 22976729 ↗
• MalfunctionAug 13, 2025Material Invagination; Structural Problem; Material Invagination; Structural Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, UPON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE "BACKFOLDED DUE TO BULBOUS ANTERIOR/POSTERIOR". SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. A NEW VALVE AND NEW DELIVERY CATHETER SYSTEM (DCS) WERE USED TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE PATIENT'S ANATOMY, SPECIFICALLY SEPTAL BULGE, CONTRIBUTED TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT THE INITIAL DEPLOYMENT OF THE VALVE WAS TOO HIGH AND THE FRAME BENT BACK INTO A SUBOPTIMAL POSITION. IT WAS FURTHER NOTED THIS WAS RELATED TO HOW THE PHYSICIAN POSITIONED THE VALVE; THERE WAS NO RELATION TO THE PATIENT'S ANATOMY OR OPERATOR ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22797580 ↗
• InjuryAug 11, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE REPLACEMENT PROCEDURE, VENOUS ACCESS WAS ACHIEVED BY THE FEMORAL VEIN. FOLLOWING THE PROCEDURE, BRUISING WAS NOTED AT THE GROIN WHERE VASCULAR ACCESS WAS ACHIEVED. ON THE FIRST POST-OPERATIVE DAY, THE PATIENT WAS DISCHARGED. LATER THAT DAY, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED). UPON ASSESSMENT, THE PATIENT WAS NOTED TO BE FEBRILE WITH A TEMPERATURE OF 101.1° F. THE PATIENT WAS ADMITTED. DIAGNOSTIC TESTS WERE PERFORMED INCLUDING OBTAINING A BLOOD SAMPLE. RESULTS OF THE BLOOD TEST SHOWED THROMBOCYTOSIS (AN ELEVATED PLATELET LEVEL). AN X-RAY WAS PERFORMED OF THE CHEST WHICH SHOWED "SIMILAR RADIOGRAPHIC APPEARANCE OF THE CHEST SINCE EARLIER [IN THE] DAY". THE PATIENT WAS PRESCRIBED ANTIBIOTIC MEDICATION FOR FIVE DAYS. THE PATIENT WAS DISCHARGED ON THE DAY AFTER ADMISSION. APPROXIMATELY ONE AND A HALF WEEKS FOLLOWING THE VALVE IMPLANT PROCEDURE, THE PATIENT SLIPPED, FELL, AND LANDED ON THE BUTTOCKS. THE FOLLOWING DAY, BRUISING WAS OBSERVED ON THE ABDOMEN, ABOVE WHERE THE BRUISING WAS LOCATED FROM THE VALVE PROCEDURE. THE PATIENT DISCUSSED THE BRUISING WITH THE PRIMARY CARDIOLOGIST WHO THEN DISCUSSED I

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fever

  MAUDE report 22772932 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P200046. One submission often covers many models, so check the product and lot details in each record.

• Z-2624-2026 · May 22, 2026 · Open, Classified
  Medtronic Harmony Delivery Catheter System
• Z-0927-2022 · Mar 2, 2022 · Open, Classified
  Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.