Harmony™ HARMONY-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000338985), received between Sep 27, 2021 and Apr 24, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Gradient Increase” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2025Structural Problem; Device Dislodged or Dislocated; Structural Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE, A PRE-IMPLANT BALLOON VALVULOPLASTY WAS PERFORMED AS A COMPLIANCE TEST TO EVALUATE FOR SUITABILITY FOR A BALLOON EXPANDABLE VALVE. FOLLOWING THE IMPLANT OF THE VALVE, AT THE END OF THE INDEX PROCEDURE, AN INTRACARDIAC ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED THE INFLOW OF THE VALVE WAS OBSERVED TO BE "FLIPPING UP AND DOWN" INTERMITTENTLY, AND INFLOW "HYPER MOBILITY". ON POST-OPERATIVE DAY 1, AN ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED ONLY SLIGHT FLOW ACCELERATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901288 ↗
• MalfunctionJan 8, 2025Gradient Increase; Structural Problem; Gradient Increase; Structural Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, THE VALVE WAS IMPLANTED IN THE RECOMMENDED LANDING ZONE. BUCKLING WAS THEN OBSERVED ON STRUTS 4-5, LIKELY DUE TO THE HORIZONTAL NATURE OF THE PATIENT'S ANATOMY. PER THE PHYSICIAN, THE VALVE WAS CONFORMING TO THE PATIENT'S ANATOMY BUT THE MID PULMONARY ARTERY HAD A CURVED ANATOMY AND THE VALVE COULD NOT TAKE THE CURVE. A GRADIENT OF 50 MILLIMETERS OF MERCURY (MMHG) WAS RECORDED. A POST- BALLOON ASSIST WAS PERFORMED WITH A 24 MILLIMETER (MM) NON-MEDTRONIC BALLOON. DUE TO THE BALLOON ASSIST, THE VALVE REPOSITIONED AND THE BUCKLING OF THE STRUTS RESOLVED. SUBSEQUENTLY, THE GRADIENT DECREASED TO 8MMHG, WHICH WAS SIMILAR TO THE PATIENT'S PRE-OPERATION MEASUREMENT (3 MMHG). AN ANGIOGRAM WAS PERFORMED AND NO PARAVALVULAR LEAK (PVL) WAS OBSERVED. AN INTRACARDIAC ECHOCARDIOGRAM (ICE) WAS PERFORMED, CONFIRMING THE PROPER FUNCTION OF THE VALVE LEAFLETS. IT WAS REPORTED THAT THE PHYSICIAN WAS HAPPY WITH THE DEVICE PERFORMANCE FOLLOWING THE BALLOON DILATION. PER THE PHYSICIAN, THE FRAME DISTORTION WAS CAUSED BY THE PATIENT'S ANATOMY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103105 ↗
• InjuryNov 20, 2024Fluid/Blood Leak; Fracture; Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Fluid/Blood Leak; Fracture; Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT APPROXIMATELY 5 DAYS FOLLOWING THE VALVE IMPLANT A TYPE I STENT FRACTURE WAS IDENTIFIED ON THE RIGHT SIDE OF THE INFLOW REGION. THE FRACTURE OCCURRED WITHOUT LOSS OF STENT INTEGRITY.

  Patient problems: Chest Pain; Dyspnea; Fatigue; Obstruction/Occlusion; Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis; Snoring; Thrombosis/Thrombus

  MAUDE report 20737362 ↗
• MalfunctionNov 12, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT ONE YEAR, FOUR MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, MODERATE PULMONARY REGURGITATION WAS NOTED. NO TREATMENT WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 20663073 ↗
• InjuryNov 11, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY THREE MONTHS, THREE WEEKS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINT OF DIZZINESS AND SHORTNESS OF BREATH. AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED AND SHOWED SECOND DEGREE ATRIO-VENTRICULAR BLOCK (AVB) AND RIGHT BUNDLE BRANCH BLOCK (RBBB). THE PATIENT WAS ADMITTED. THE NEXT DAY, A SECOND ECG SHOWED FIRST DEGREE AVB AND RBBB WHICH WAS NOTED TO BE "NORMAL STATUS" FOR THE PATIENT. THE SAME DAY, A STRESS TEST WAS PERFORMED AND SHOWED THE PATIENT WAS IN NORMAL SINUS RHYTHM, THERE WAS A 2:1 ABV, AND RARE PREMATURE ATRIAL CONTRACTIONS. DURING THE STRESS TEST, THE PATIENT FAILED TO ACHIEVE THE TARGET HEART RATE. THE PATIENT WAS DISCHARGED TWO DAYS AFTER PRESENTATION. NO FURTHER TREATMENT WAS REPORTED.

  Patient problems: Dizziness; Dyspnea; Non specific EKG/ECG Changes

  MAUDE report 20659100 ↗
• InjuryJul 27, 2023Degraded; Gradient Increase; Degraded; Gradient Increase

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE MEAN GRADIENT BEFORE THE IMPLANT OF THE VALVE WAS 40 MILLIMETERS OF MERCURY (MMHG), AND THE MEAN GRADIENT AFTER THE VALVE WAS IMPLANTED WAS 4 MMHG. PER THE PHYSICIAN, THERE WAS NO KNOWN PATIENT ANATOMICAL FACTORS THAT CONTRIBUTED TO THE ELEVATED GRADIENT. ADDITIONALLY, THERE WAS NO EVIDENCE OF LEAFLET THICKENING ON THE TRANSCATHETER PULMONARY VALVE, AND THE LOCATION OF THE STENOSIS WAS SUB VALVULAR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Stenosis

  MAUDE report 17407638 ↗
• InjuryOct 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, SUCCESSIVE ANGIOGRAPHIC IMAGING WAS PERFORMED TO CONFIRM THE POSITION OF THE DELIVERY CATHETER SYSTEM (DCS) AND TO VISUALIZE VALVE DEPLOYMENT. FOLLOWING FULL DEPLOYMENT, THE VALVE BEGAN TO DISLODGE. AN EPISODE OF PREMATURE VENTRICULAR CONTRACTIONS WERE NOTED. FOR APPROXIMATELY SIXTY SECONDS, THE VALVE FRAME CONTINUED TO DISLODGE AND MIGRATED INTO THE RIGHT VENTRICLE. A NON-MEDTRONIC CATHETER WIRE WAS PLACED THROUGH THE VALVE AND HELD SECURELY TO THE WALL OF THE RIGHT VENTRICLE. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. THE VALVE WAS EXPLANTED AND A NON-MEDTRONIC SURGICAL PULMONARY BIOPROSTHETIC VALVE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia; Non specific EKG/ECG Changes

  MAUDE report 12652760 ↗
• InjurySep 27, 2021No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, A SECOND TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE WAS IMPLANTED. THE REASON FOR AN ADDITIONAL VALVE WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 12533162 ↗

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.