LOTUS Edge Valve SystemRecalls & reported problems across all models

We found 3 models of LOTUS Edge Valve System by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 278 adverse event reports in the FDA's MAUDE database, received between May 31, 2019 and Jun 3, 2026 — classified as 50 deaths, 177 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (35 reports).

3 FDA recall records name at least one of these models by its device identifier.

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

LOTUS Edge Valve System 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. Nov 17, 2020Class ITerminated

   Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.

   Z-0730-2021 · Root cause: Device Design · Recall details · FDA record ↗

2. Nov 17, 2020Class ITerminated

   Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.

   Z-0729-2021 · Root cause: Device Design · Recall details · FDA record ↗

3. Nov 17, 2020Class ITerminated

   Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.

   Z-0728-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported LOTUS Edge Valve System problems

LOTUS Edge Valve System models

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

• LOTUS Edge™ Valve System H749LVSUS270

  Aortic valve, prosthesis, percutaneously delivered
  1 recall21 deaths118 reports
• LOTUS Edge™ Valve System H749LVSUS250

  Aortic valve, prosthesis, percutaneously delivered
  1 recall19 deaths91 reports
• LOTUS Edge™ Valve System H749LVSUS230

  Aortic valve, prosthesis, percutaneously delivered
  1 recall10 deaths69 reports

Recent LOTUS Edge Valve System adverse event reports

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

• DeathJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. A 27MM LOTUS EDGE VALVE WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2026 THE PATIENT DIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385134 ↗
• DeathJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. A 27MM LOTUS EDGE VALVE WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT DIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25379566 ↗
• DeathMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. IN (B)(6) 2020, THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE AND WAS SUCCESSFULLY IMPLANTED WITH A 25MM LOTUS EDGE VALVE. TWENTY-TWO (22) DAYS POST PROCEDURE THE PATIENT DIED OF UNREPORTED CAUSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060373 ↗
• DeathJan 3, 2024Degraded; Degraded

  IT WAS REPORTED VIA VOLUNTARY MEDWATCH MW5149228 THAT VALVE FAILURE, BLOOD IN LUNGS AND DEATH OCCURRED IN 2020, A 25MM LOTUS EDGE VALVE WAS IMPLANTED. IN THE (B)(6) OF 2022, THE PATIENT STARTED EXPERIENCING COMPLICATIONS. THE PRIMARY HEART SURGEON BELIEVED IT WAS NOT RELATED TO THE LOTUS EDGE VALVE. ON (B)(6) 2022, THE PATIENT WOKE UP FROM SLEEP UNABLE TO BREATH. THE PATIENT'S LUNGS WERE FILLING WITH BLOOD AND WAS RUSHED TO THE EMERGENCY ROOM (ER). THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) FOR FIVE DAYS. UPON RETURNING HOME, THE PATIENT MET WITH THEIR HEART SURGEON, AND IT WAS CONCLUDED THE 25MM LOTUS EDGE VALVE WAS FAILING (COLLAPSING IN ON ITSELF) CAUSING THE BLOOD TO FLOW INTO THE LUNGS. SURGERY WAS UNABLE TO BE SCHEDULED IN TIME. THE PATIENT DIED AS A RESULT OF THE LOTUS EDGE VALVE FAILURE.

  Patient problems: Dyspnea; Pulmonary Edema

  MAUDE report 18435049 ↗
• DeathJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. IN SEPTEMBER 2020, THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH A 27MM LOTUS EDGE VALVE. IN DECEMBER 2020, THE PATIENT WAS FOUND DECEASED OF UNREPORTED CAUSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17053597 ↗
• DeathNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED 29 DAYS POST IMPLANT OF A 27MM LOTUS EDGE VALVE. THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15844986 ↗
• DeathNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH A 25MM LOTUS EDGE VALVE IMPLANT PROCEDURE IN (B)(6) 2020. TWENTY FIVE DAYS POST INDEX PROCEDURE, THE PATIENT DIED.

  Patient problems: Insufficient Information

  MAUDE report 12903600 ↗
• DeathJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. THE PATIENT WAS TREATED WITH A 25MM LOTUS EDGE VALVE. NO PATIENT COMPLICATIONS WERE REPORTED. THE FOLLOWING DAY THE PATIENT PASSED AWAY.

  Patient problems: Death

  MAUDE report 11238451 ↗
• MalfunctionDec 9, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT A CATHETER KINK OCCURRED. THE PATIENT HAD A CALCIFIED AND TORTUOUS SEVERELY BILATERAL COMMON ILIAC ARTERY AND THE RIGHT CORONARY CUSP WAS MILDLY CALCIFIED. THE LOTUS EDGE VALVE SYSTEM WAS NOTED TO BE KINKED WHILE IT ADVANCED TO THE AORTIC ARCH. A SECOND LOTUS EDGE VALVE SYSTEM WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10977422 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROTECTED TAVR STUDY: IT WAS REPORTED THAT COMPLETE ATRIOVENTRICULAR (AV) BLOCK OCCURRED. THE PATIENT WAS ENROLLED INTO THE PROTECTED TAVR STUDY AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE PATIENT WAS ON A PRIOR REGIMEN OF ANTIPLATELET MEDICATIONS AND ASPIRIN. AFTER HEPARIN WAS GIVEN AND DURING THE START OF THE PROCEDURE, THE ACTIVATED CLOTTING TIME (ACT) WAS 274 SEC. AN ISLEEVE INTRODUCER SHEATH WAS PLACED AND THE AORTIC VALVE WAS TREATED WITH BALLOON VALVULOPLASTY AND SUBSEQUENT DEPLOYMENT OF A 23MM LOTUS EDGE VALVE. ONE DAY POST INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AV BLOCK. AN ELECTROPHYSIOLOGY STUDY WAS PERFORMED AS A DIAGNOSTIC AND A PERMANENT PACEMAKER WAS IMPLANTED. TWO DAYS POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED ON 81 MG OF ASPIRIN. IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE, POST-DILATION OF THE LOTUS EDGE VALVE WAS PERFORMED. 1-DAY POST INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH LEFT BUNDLE BRANCH BLOCK(LBBB) FOR WHICH OUTPATIENT FOLLOW-UP WAS PERFORMED. ON THE SAME DAY, THE COMPLETE AV BLOCK WAS CONSIDERED RECOVERED. THE LBBB WAS CONSIDERED RE

  Patient problems: Arrhythmia; Complete Heart Block; Heart Block

  MAUDE report 10971418 ↗
• DeathDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRACEREBRAL HEMORRHAGE AND DEATH OCCURRED. THE PATIENT SUFFERED FROM AN INTRACEREBRAL HEMORRHAGE FOLLOWING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE PATIENT RECEIVED HOSPICE CARE WITH INTRAVENOUS COMFORT CARE MEDICATIONS. THE PATIENT DIED IN THE HOSPITAL AND WAS NOT DISCHARGED POST TAVR.

  Patient problems: Death; Stroke/CVA

  MAUDE report 10950890 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROTECTED TAVR STUDY. IT WAS REPORTED THAT STROKE OCCURRED. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN. THE SUBJECT WAS NOT ON A PRIOR REGIMEN OF ASPIRIN AND ANTIPLATELET OTHER THAN ASPIRIN AT THE TIME OF INDEX PROCEDURE. THE SUBJECT RECEIVED LOADING DOSE OF ASPIRIN. AFTER HEPARIN HAS BEEN GIVEN AND DURING START OF PROCEDURE, THE ACTIVATED CLOTTING TIME (ACT) WAS 131 SEC. AN ISLEEVE INTRODUCER SHEATH WAS PLACED AND THEN THE NATIVE AORTIC VALVE WAS TREATED WITH BALLOON VALVULOPLASTY IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). A 23MM LOTUS EDGE VALVE WAS ADVANCED TO TREAT THE AORTIC VALVE. DURING DEPLOYMENT, A TWISTED POST WAS OBSERVED PRIOR TO LOCKING OF THE VALVE. THE PHYSICIAN ATTEMPTED TO MITIGATE THE TWISTED POST BY CENTRALIZING THE LOTUS EDGE DELIVERY SYSTEM CATHETER WHICH WAS UNSUCCESSFUL. A PARTIAL RESHEATH AND FULL RESHEATH WERE PERFORMED IN ACCORDANCE WITH THE IFU WITH THE SAME RESULT. THE 23MM LOTUS EDGE VALVE WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER 23MM LOTUS EDGE VALVE WHICH WAS ABLE TO BE SUCCESSFULLY IMPLANTED IN THE CORRECT ANATOMICAL LOCATION. ON THE SAME DAY, POST INDEX PROCEDURE, THE SUBJECT WAS EVALUATED EMERGENTLY

  Patient problems: Stroke/CVA

  MAUDE report 10949638 ↗
• InjuryDec 4, 2020Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AORTIC DISSECTION AND PERICARDIAL EFFUSION OCCURRED. A 25MM LOTUS EDGE VALVE WAS SELECTED FOR USE IN A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. AN ISLEEVE INTRODUCER SHEATH WAS PLACED VIA A RIGHT TRANSFEMORAL ACCESS. THE AORTIC VALVE WAS TREATED WITH BALLOON VALVULOPLASTY WITH A 20MM NON-BSC BALLOON CATHETER. THE AORTIC VALVE WAS TREATED WITH SUBSEQUENT DEPLOYMENT OF THE 25 MM LOTUS EDGE VALVE. SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED PARTIAL RE-SHEATHING AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN EXPERIENCED DIFFICULTY LOCKING THE VALVE, BUT WAS ULTIMATELY SUCCESSFUL. DURING FINAL DEPLOYMENT, A PERICARDIAL EFFUSION WAS OBSERVED VIA TRANSTHORACIC ECHOCARDIOGRAM. THE PHYSICIAN SUSPECTED THERE WAS A SMALL DISSECTION IN THE ANNULUS THAT OCCURRED DURING THE PARTIAL RECAPTURE OR PRIOR TO THE FINAL VALVE DEPLOYMENT. THE AORTIC DISSECTION WAS SEALED BY THE FINAL DEPLOYMENT OF THE LOTUS EDGE VALVE AND THUS MITIGATED FURTHER EXTRACTION OF BLOOD IN THE PERICARDIAL SPACE. HOWEVER, THE PHYSICIAN DID NOT KNOW THE VALVE WOULD SEAL THE DISSECTION,

  Patient problems: Aortic Dissection; Pericardial Effusion

  MAUDE report 10945528 ↗
• DeathDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEFT BUNDLE BRANCH BLOCK (LBBB), VESSEL OCCLUSION, VENTRICULAR FIBRILLATION, HYPOTENSION, AND DEATH. THE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF THE 27MM LOTUS EDGE VALVE. AFTER DEPLOYMENT, THE PATIENT WENT INTO LBBB. THE POSITIONING WAS OBSERVED TO BE APPROXIMATELY 7MM DEEP, SO THE PHYSICIAN DECIDED TO REPOSITION HIGHER. SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED RE-SHEATHING AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE PATIENT'S RHYTHM RETURNED TO A NORMAL SINUS RHYTHM AND THE PHYSICIAN'S WERE SATISFIED WITH THE VALVE POSITIONING. AFTER THE LOTUS EDGE VALVE WAS RELEASED, THE PATIENT'S LEFT CORONARY SYSTEM SHUT DOWN, AS SEEN VIA ANGIOGRAPHY. THE PATIENT EXPERIENCED HYPOTENSION AND CARDIAC RHYTHM CHANGES. TWO CORONARY STENTS WERE PLACED; HOWEVER, THE PATIENT HAD SEVERAL ROUNDS OF VENTRICULAR FIBRILLATION. CHEST COMPRESSIONS WERE STARTED AND WENT FOR 45 MINUTES. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE INTENSIVE CARE UNIT, WHERE LATER, PASSED AWAY.

  Patient problems: Arrhythmia; Death; Low Blood Pressure/ Hypotension; Stenosis; Ventricular Fibrillation

  MAUDE report 10945195 ↗
• InjuryDec 1, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. PRO THE PATIENTS NATIVE AORTIC VALVE ANATOMY CONSISTED OF MODERATE LEAFLET CALCIFICATION, MODERATE-TO-SEVERE TORTUOSITY, AND A HORIZONTAL AORTA. A 27MM LOTUS EDGE VALVE WAS SELECTED TO TREAT AORTIC STENOSIS. DURING DEPLOYMENT, THE LOTUS EDGE VALVE EXHIBITED ASYMMETRIC UNSHEATHING. THE OBSERVATION OCCURRED TWICE; ONCE WHEN THE VALVE WAS DEPLOYED TOO HIGH AND ONCE WHEN THE VALVE WAS DEPLOYED TOO LOW. SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED THREE PARTIAL AND ONE COMPLETE RE-SHEATHINGS AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). AFTER THE INDEX PROCEDURE, THE PATIENT DEVELOPED LEFT SIDED WEAKNESS, FACIAL DROOP, AND HAD DIFFICULTY SWALLOWING. AN MRI WAS PERFORMED WHICH SHOWED SIGNS OF A CVA IN THE RIGHT MIDDLE CEREBRAL ARTERY. THE PATIENT WAS IMPLANTED WITH A PEG TUBE DUE TO THE DIFFICULTY SWALLOWING AND WAS DISCHARGED TO INPATIENT REHABILITATION.

  Patient problems: Stroke/CVA

  MAUDE report 10925362 ↗

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