WALLSTENT EndoprosthesisRecalls & reported problems across all models

We found 18 models of WALLSTENT Endoprosthesis by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 154 adverse event reports in the FDA's MAUDE database, received between Mar 30, 2018 and Jul 13, 2026 — classified as 45 injuries, 109 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (49 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. 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

Most reported WALLSTENT Endoprosthesis problems

WALLSTENT Endoprosthesis models

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

• WALLSTENT® Endoprosthesis H965403130

  STENT, CORONARY
  35 reports
• WALLSTENT® Endoprosthesis H965402130

  STENT, CORONARY
  23 reports
• WALLSTENT® Endoprosthesis H965403330

  STENT, CORONARY
  21 reports
• WALLSTENT® Endoprosthesis H965404130

  Prosthesis, tracheal, expandable
  11 reports
• WALLSTENT® Endoprosthesis H965403320

  STENT, CORONARY
  10 reports
• WALLSTENT® Endoprosthesis H965403120

  STENT, CORONARY
  9 reports
• WALLSTENT® Endoprosthesis H965404520

  Prosthesis, tracheal, expandable
  7 reports
• WALLSTENT® Endoprosthesis H965404320

  Prosthesis, tracheal, expandable
  6 reports
• WALLSTENT® Endoprosthesis H965405120

  Prosthesis, tracheal, expandable
  6 reports
• WALLSTENT® Endoprosthesis H965402120

  STENT, CORONARY
  4 reports
• WALLSTENT® Endoprosthesis H965403310

  STENT, CORONARY
  4 reports
• WALLSTENT® Endoprosthesis H965404110

  Prosthesis, tracheal, expandable
  3 reports
• WALLSTENT® Endoprosthesis H965404120

  Prosthesis, tracheal, expandable
  3 reports
• WALLSTENT® Endoprosthesis H965404310

  Prosthesis, tracheal, expandable
  3 reports
• WALLSTENT® Endoprosthesis H965405110

  Prosthesis, tracheal, expandable
  3 reports
• WALLSTENT® Endoprosthesis H965402110

  SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
  2 reports
• WALLSTENT® Endoprosthesis H965403110

  STENT, CORONARY
  2 reports
• WALLSTENT® Endoprosthesis H965404510

  Prosthesis, tracheal, expandable
  2 reports

Recent WALLSTENT Endoprosthesis adverse event reports

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

• MalfunctionJul 13, 2026Premature Activation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 14X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE. DURING DEVICE DELIVERY, THE STENT BECAME DISLODGED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT REMAINED STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25806683 ↗
• MalfunctionJul 7, 2026Break; Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT SHAFT BREAK, REMOVAL DIFFICULTY, AND PARTIAL DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY VEINS. A 12X90/8FR UNI PLUS HALO 75CM WALLSTENT UNI WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS DELIVERED INTO THE BODY AND DEPLOYED AFTER REACHING THE LESION SITE. DURING THE DEPLOYMENT, THE DELIVERY SHAFT WAS FRACTURED, AND THE TAIL END COULD NOT BE PULLED. AFTER MANY ROTATIONS, THE STENT COULD NOT BE PULLED. THE STENT WAS ONLY DEPLOYED AT THE TIP END, AND THE BACK PART WAS NOT DEPLOYED. THE PHYSICIAN USED THE ADJUSTABLE CURVED SHEATH TO PULL OUT THE STENT AFTER MANY ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS POST PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25738421 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A SELF-EXPANDING 75CM WALLSTENT ENDOPROSTHESIS WAS CHOSEN FOR VENOUS RECANALIZATION AND STENT PLACEMENT IN THE LOWER EXTREMITY. WHEN THE PACKAGE WAS OPENED, THE CATHETER OUTSIDE THE STENT WAS FOUND TO BE BROKEN, WITH A ROUGH SURFACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521880 ↗
• MalfunctionMar 5, 2026Difficult to Remove; Activation Failure

  IT WAS REPORTED THAT STENT FAILURE TO DEPLOY AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 14X90/9FR UNI PLUS 75CM WALLSTENT UNI STENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON REACHING THE LESION SITE, THE PULL ROD WAS RETRACTED TO RELEASE THE STENT, BUT THE STENT FAILED TO DEPLOY. DIFFICULTY WITHDRAWING THE STENT ALONG THE GUIDEWIRE WAS NOTED AND AN EXTERNAL ATTEMPT TO RELEASE THE PULL ROD WHERE IT COULD BE RETRACTED WAS MADE, HOWEVER, THE STENT STILL FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521389 ↗
• MalfunctionFeb 13, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE COMMON ILIAC VEIN. A 75CM WALLSTENT UNI WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337580 ↗
• InjuryFeb 12, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED CAUSING PAIN AND VESSEL TRAUMA. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 14X90/9FR UNI PLUS 75CM WALLSTENT UNI STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS FOUND THAT THE TIP OF THE STENT WAS IRREGULAR IN SHAPE AND HAD ABNORMAL PROTRUDES, WHICH CAUSED SEVERE PAIN TO THE PATIENT. AFTER REMOVAL, IT WAS NOTED THAT THE VESSEL'S INTIMA HAD BEEN TORN AND DAMAGED, AND IT HAD BECOME ATTACHED TO THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT CONDITION WAS STABLE FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE 50% STENOSED TARGET LESION WAS NOTED. THE SHAPE OF THE STENT'S TIP END WAS IRREGULAR WITH ABNORMAL PROTRUSIONS. WHEN IT WAS RELEASED, THE PATIENT EXPERIENCED SEVERE PAIN. UPON WITHDRAWAL, IT WAS OBSERVED THAT THE INNER LINING OF THE BLOOD VESSEL WAS TORN AND DAMAGED AND THE ABNORMAL PROTRUDING STENT AND THERE WAS NO TREATMENT AVAILABLE FOR THE TIME BEING.

  Patient problems: Pain; Perforation of Vessels

  MAUDE report 24327448 ↗
• MalfunctionJan 29, 2026Activation, Positioning or Separation Problem; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 16X60/9FR UNI PLUS 75CM WALLSTENT UNI STENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE STENT, AND ADVANCEMENT WAS NOT SMOOTH. AFTER REACHING THE LESION LOCATION, THE SHAFT WAS PULLED TO DEPLOY THE STENT; HOWEVER, THE STENT DID NOT RESPOND. RESISTANCE OCCURRED WHEN APPROXIMATELY ONE THIRD OF THE STENT HAD BEEN DEPLOYED. THE STENT WAS WITHDRAWN ALONG THE GUIDEWIRE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210405 ↗
• MalfunctionDec 22, 2025Adverse Event Without Identified Device or Use Problem; Activation Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02DEC2025. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 75CM WALLSTENT-UNI ENDOPROSTHESIS SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE STENT ALREADY DEPLOYED FROM THE DELIVERY SYSTEM AND THE STENT CUP WAS NOTED TO BE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23868078 ↗
• MalfunctionDec 22, 2025Activation Failure; Activation Failure

  IT WAS REPORTER THAT THE STENT FAILED TO DEPLOY RESULTING IN PROCEDURE CANCELLATION. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY VEINS. A 75CM WALLSTENT UNI WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED PROPERLY DESPITE MULTIPLE ATTEMPTS. THE DEVICE WAS REMOVED COMPLETELY AND INTACT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS CONCLUDED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PROCEDURE WAS CANCELLED AS A RESULT OF THE DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864530 ↗
• MalfunctionDec 1, 2025Adverse Event Without Identified Device or Use Problem; Activation Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED VEIN. A 16MM X 90MM X 75CM WALLSTENT ENDOPROSTHESIS SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING ATTEMPTED DEPLOYMENT, THE DELIVERY SYSTEM WOULD NOT RELEASE THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A DAMAGED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687800 ↗
• MalfunctionNov 13, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT HAD PULMONARY MALIGNANCY AND SUPERIOR VENA CAVA COMPRESSION. A 12MM X 90MM WALLSTENT ENDOPROSTHESIS STENT SELF EXPANDING WAS SELECTED FOR USE IN THE SUPERIOR VENA CAVA. DURING THE PROCEDURE, DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED THAT THE STENT HAD KINK MARKS, WHICH WERE CONFIRMED AFTER THE STENT WAS REMOVED FROM THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23548017 ↗
• MalfunctionSep 11, 2025Nonstandard Device; Defective Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT PROFILE PROBLEM OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERIOR VENA CAVA. A 75CM WALLSTENT ENDOPROSTHESIS SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED AS IT WAS FOUND THAT THE LENGTH OF THE STENT MAY BE TO THE HEART. THE ORIGINAL STENT MEASURED 90 MM BUT WAS 150 MM INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO FURTHER COMPLICATIONS NOTED AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED, MILDLY TORTUOUS, AND MODERATELY CALCIFIED. THE PRODUCT INNER POUCH MATCHES THE OUTER CARTON/SHELF CARTON. THE STENT WAS FOUND TO BE THE WRONG SIZE TO THE LESION LENGTH WHILE INSIDE THE PATIENT'S BODY, WITH 1/3 OF IT INSIDE THE PATIENT'S HEART. THE STENT WAS FULLY RE-CONSTRAINED DURING WITHDRAWAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026551 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EMBOLIZATION AND THROMBOSIS OCCURRED. THE PATIENT WAS ADMITTED FOR AN ILIAC VEIN EMBOLISM AND UNDERWENT MULTIPLE PROCEDURES ON (B)(6) 2025, INCLUDING INFERIOR VENA CAVA ANGIOGRAPHY, FILTER IMPLANTATION, LEFT LOWER EXTREMITY ANGIOGRAPHY, BALLOON DILATION, AND LEFT ILIAC VEIN STENT PLACEMENT. A 75CM WALLSTENT UNI WAS SELECTED FOR USED. THE PROCEDURE REVEALED LEFT ILIAC VEIN STENOSIS, AFTER BALLOON DILATION, A STENT WAS PLACED. HOWEVER, REPEATED EMBOLIZATION OF THE INFLOW TRACT CAUSED BLOOD STASIS AND THROMBOSIS. RE-INTERVENTIONAL TREATMENT, INCLUDING THROMBECTOMY, BALLOON DILATION AND CATHERIZATION THROMBOLYSIS REDUCED THE THROMBOSIS AND RESTORED BLOOD FLOW. THERE WERE NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Embolism/Embolus; Thrombosis/Thrombus

  MAUDE report 22940301 ↗
• MalfunctionApr 11, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 25% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED ILIAC VEIN. A 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE. UPON RELEASING, IT WAS NOTED THAT THE STENT WAS DIFFICULT TO DELIVER, AND PRE-DELIVERY WAS FAILED. THE STENT WAS PULLED OUT, AND IT WAS NOTED THAT THERE WERE BURRS AT THE TIP OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21828818 ↗
• MalfunctionApr 2, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE UPON ANALYSIS COMPLETED ON (B)(6)2025. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 14X90/9 WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS INSERTED INTO THE PATIENT; HOWEVER, THE PRODUCT WAS UNABLE TO TRAVERSE THE LESION. AS A RESULT, THE PHYSICIAN SUBSEQUENTLY WITHDREW THE PRODUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH A DIFFERENT LOT NUMBER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753526 ↗

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