ELUVIA™ H74939294700410Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729876694), received between Nov 30, 2021 and Jan 8, 2026 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (6 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Premature Activation

  IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 7X40, 130 CM ELUVIA STENT WAS DELIVERED THROUGH A .035 AMPLATZ GUIDEWIRE VIA CONTRALATERAL APPROACH TO OVERLAP AND EXTEND LENGTH OF PREVIOUSLY DEPLOYED STENT. HOWEVER, PRIOR TO REACHING THE TARGET LESION AND REMOVING THE YELLOW SAFETY LOCK MECHANISM, THE STENT DEPLOYED PREMATURELY. AN ATTEMPT WAS MADE TO DEPLOY A NON-BOSTON SCIENTIFIC STENT, BUT UNSUCCESSFUL IN REACHING THE TARGET LOCATION. THE PHYSICIAN DECIDED AGAINST PURSUING ANY FURTHER INTERVENTION AND CHOSE NOT TO DEPLOY A STENT, ENDING THE CASE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PREVIOUSLY DEPLOYED 7X120 ELUVIA WAS NOT LONG ENOUGH TO COVER ENTIRETY THE LESION, WHICH IS WHY THE 7X40 WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003824 ↗
• InjuryJun 2, 2025Defective Device; Defective Device

  IT WAS REPORTED VIA A CLINICAL STUDY THAT THE STENT WAS UNDERSIZED IN DIAMETER, REQUIRING INTERVENTION. ON (B)(6) 2024, OCCLUSION WAS NOTED IN THE LEFT OSTIAL SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS TREATED BY DILATION USING 5 X 40 MM MUSTANG PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON. TREATMENT WAS ALSO PERFORMED FOR THROMBOTIC OCCLUSION IN THE LEFT SFA AND POPLITEAL ARTERIES BY THROMBECTOMY USING PENUMBRA LIGHTNING BOLT CATHETER. SUBSEQUENTLY THE DISTAL ASPECT OF THE SFA STENT WAS TREATED BY BALLOON ANGIOPLASTY USING 5 X 150 MM STERLING PTA BALLOON, 6 X 150 MM RANGER DRUG COATED BALLOON. THIS WAS FOLLOWED BY PLACEMENT OF 7 X 40 MM ELUVIA DRUG ELUTING STENT FROM THE LEFT DISTAL COMMON FEMORAL ARTERY AND LEFT OSTIAL SFA, AND THE STENT WAS POST DILATED USING 6 X 40 MM MUSTANG PTA BALLOON. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. FINAL ANGIOGRAMS DEMONSTRATE BRISK FLOW THROUGH THE STENTED SEGMENT WITH THREE-VESSEL RUNOFF TO THE FOOT. ON (B)(6) 2024, THE EVENT WAS CONSIDERED TO BE RESOLVED, AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2024, THE PREVIOUSLY PLACED 7 X 40 MM ELUVIA DRUG ELUTING STENT APPEARED TO BE UN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125710 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  S2444 ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT ACUTE STENT THROMBOSIS OCCURRED. ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL WITH THE COMPLAINTS OF COLD TOES. SUBSEQUENTLY, RIGHT ARTERIAL DOPPLER ULTRASONOGRAPHY (DUS) WAS PERFORMED WHICH REVEALED 50% STENOSIS IN THE EXTERNAL ILIAC, COMMON FEMORAL, AND DISTAL POPLITEAL ARTERIES. ON (B)(6) 2024, THE SUBJECT USED A DOPPLER AT HOME BUT COULD NOT FIND ANY PULSE IN RIGHT LOWER EXTREMITY (RLE), HENCE CALLED EMERGENCY MEDICAL SERVICES (EMS). THE SUBJECT WAS THEN PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF PAIN RUNNING FROM THE BOTTOM OF FOOT UP TO THE BACK OF THE KNEE. THE SUBJECT ALSO EXPERIENCED NUMBNESS, TINGLING SENSATION IN RLE AND SHORTNESS OF BREATH (SOB). SUBSEQUENTLY, THE SUBJECT WAS STARTED ON A HIGH-INTENSITY HEPARIN DRIP AND WAS ADMITTED TO THE CRITICAL CARE UNIT (CCU). ON THE SAME DAY, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF THE AORTA WITH BILATERAL RUNOFF REVEALED: RIGHT LOWER EXTREMITY (TARGET LIMB-RLE): OCCLUDED RIGHT FEMOROPOPLITEAL STENTS WITH RECONSTITUTION ALONG THE CAUDAL MARGIN OF THE POPLITEAL ARTERY VIA GENICULAR COLLATERALS. THERE WAS A TWO-VESSEL RUNOFF TO THE RIGHT ANKLE VIA THE POSTERIOR TIBIAL AND PE

  Patient problems: Dyspnea; Numbness; Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 19974573 ↗
• MalfunctionFeb 8, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. THIS 7X40, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN A LEFT LOWER EXTREMITY ANGIOGRAM PROCEDURE. THE DEVICE WAS PREPARED, AND AS IT WAS BEING LOADED ON THE GUIDEWIRE THE PROTECTIVE SHEATH WAS EXPOSED, AND THE STENT BEGAN TO DEPLOY OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ELUVIA STENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668072 ↗
• MalfunctionDec 20, 2023Difficult to Insert; Premature Activation; Activation, Positioning or Separation Problem; Difficult to Insert; Premature Activation; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. THIS 7X40, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN A SUPERFICIAL FEMORAL ARTERY ANGIOGRAM PROCEDURE. DIFFICULTY WAS EXPERIENCED DURING INSERTION OF THE STENT SYSTEM AT THE HUB OF THE 6FR SHEATH. THEN IT WAS NOTICED THAT THE STENT HAD INADVERTENTLY DEPLOYED, PREVENTING THE SYSTEM FROM BEING INTRODUCED INTO THE SHEATH. THE DEVICE WAS REMOVED, AND A SECOND STENT OF THE SAME SIZE WAS SUCCESSFULLY DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365850 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED, REQUIRING AN ADDITIONAL INTERVENTION. ON (B)(6) 2023, AN AORTOGRAM, LEFT LOWER EXTREMITY ARTERIOGRAM, ATHERECTOMY, BALLOON PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, AND STENTING PROCEDURE WAS PERFORMED. THE SUPERFICIAL FEMORAL ARTERY LESION WAS OCCLUDED AT ITS ORIGIN. THE LESION WAS UNABLE TO BE ACCESSED VIA THE RIGHT COMMON FEMORAL ARTERY; THEREFORE, THE LEFT PEDIS ARTERY WAS ACCESSED AND THE LESION WAS ACCESSED FROM BELOW. ATHERECTOMY WAS PERFORMED, FOLLOWED BY BALLOON ANGIOPLASTY USING TWO OVERLAPPING INFLATIONS, EACH HELD FOR THREE MINUTES. A SIGNIFICANT DISSECTION OCCURRED AT THE ORIGIN OF THE SFA DUE TO THE NATURE OF THE DISEASE AND PATIENT ANATOMY, AND NOT DUE TO ANY DEVICE PER THE PHYSICIAN. AN ADDITIONAL FIVE-MINUTE INFLATION WAS PERFORMED WITH THE BALLOON, WITH LITTLE IMPROVEMENT. THEREFORE, THIS 7X40, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS DEPLOYED. REPEAT IMAGING SHOWED A GOOD RESULT. THEN ANOTHER BALLOON WAS ADVANCED INTO THE DORSALIS PEDIS ARTERY TO ACHIEVE HEMOSTASIS. THE MICROPUNCTURE DILATOR WAS REMOVED PRIOR TO INFLATING THE BALLOON ACROSS THE ACCESS SITE AND WAS HELD FOR THREE MINUTES. REPEAT IMAGING S

  Patient problems: Arteriosclerosis/ Atherosclerosis; Restenosis

  MAUDE report 17885054 ↗
• MalfunctionAug 2, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. THIS 7X40, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN A PROCEDURE FOR PERIPHERAL ARTERY DISEASE. UPON OPENING THE DEVICE PACKAGING, THE STENT WAS PARTIALLY DEPLOYED. IT APPEARED THAT THE THUMBWHEEL PROTECTOR AND REAR BLUE PULL TAB WERE INTACT, AND THE DISTAL PORTION OF THE STENT WAS EXPOSED AND PARTIALLY FLARED OUT. THE PROCEDURE WAS COMPLETED USING A NEW STENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442213 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  S2444 ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT THROMBOSIS AND DISSECTION OCCURRED DURING THE INDEX PROCEDURE. ON (B)(6) 2023, THE SUBJECT UNDERWENT TREATMENT WITH ELUVIA DRUG-ELUTING STENT AND RANGER DRUG COATED BALLOONS AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY 9SFA) EXTENDING INTO RIGHT MID SFA WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 6 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 7 MM WITH LESION LENGTH OF 40 MM AND 70% STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY STUDY DEVICES, 7 MM X 60 MM ELUVIA DRUG-ELUTING STENT AND 6 MM X 40 MM RANGER DRUG-COATED BALLOON. FOLLOWING POST DILATION WITH A NON-BSC BALLOON WAS PERFORMED, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. THE TARGET LESION #002 WAS IN THE RIGHT COMMON FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 7 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 7 MM WITH LESION LENGTH OF 60 MM AND 80% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY STUDY DEVICE, 7 MM X 60 MM RANGER DRUG-COATED BALLOON. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS W

  Patient problems: Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 16468653 ↗
• MalfunctionFeb 3, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. A 7MM X 40MM, 130CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN A STENTING PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY. HOWEVER, THE DISTAL END OF THE STENT WAS EXPOSED OUTSIDE THE TIP OF THE DELIVERY SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16295389 ↗
• MalfunctionNov 9, 2022Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT DEPLOYED BY ITSELF BEFORE ENTERING THE PATIENT. AN 7MM X 40MM X 130CM ELUVIA DRUG-ELUDING VASCULAR STENT WAS CHOSEN AS THE TREATMENT FOR PERIPHERAL ARTERY DISEASE OF THE SUPERFICIAL FEMORAL ARTERY. DURING THE PROCEDURE, THE STENT BEGAN TO PREMATURELY DEPLOY INSIDE OF THE SHEATH. THE SHEATH AND ELUVIA WERE REMOVED TOGETHER, AND IT AS NOTED THAT THE STENT WAS FULLY DEPLOYED WITHIN THE SHEATH. A DIFFERENT DEVICE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15763895 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL: IT WAS REPORTED THAT AN EMBOLISM OCCURRED DURING THE TREATMENT OF THE TARGET LESION. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG COATED BALLOONS AND ELUVIA DRUG ELUTING STENT ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE ENTIRE LENGTH OF RIGHT SUPERFICIAL FEMORAL ARTERY. THE LESION HAD A PROXIMAL REFERENCE VESSEL DIAMETER OF 6.0 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5.0 MM WITH LESION LENGTH OF 300 MM. THE LESION WAS 100% STENOSED AND CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT, LASER ATHERECTOMY WAS PERFORMED WITH A TURBO-ELITE CATHETER. PRE-DILATION WAS PERFORMED WITH A 4.0 MM X 220 MM STERLING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. TREATMENT OF THE TARGET LESION WAS PERFORMED BY DILATATION WITH A 5.0 MM X 200 MM AND A 6.0 MM X 200 MM RANGER DRUG COATED BALLOONS. THIS WAS FOLLOWED BY A PLACEMENT OF 7.0 MM X 40 MM ELUVIA DRUG ELUTING STENT. DURING THE PROCEDURE, AN EMBOLISM WAS NOTED IN THE TARGET LESION. IN RESPONSE TO THE EMBOLISM, MECHANICAL THROMBECTOMY WAS PERFORMED AND THE COMPLICATION WAS RESOLVED. POST DILATATION WAS PERFORMED WITH 6 MM X 40 MM MUSTANG PTA

  Patient problems: Embolism/Embolus

  MAUDE report 12900413 ↗