WALLSTENT® Endoprosthesis H965403120Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729204008), received between Feb 27, 2020 and Apr 1, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Defective Device” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT STENT PROFILE PROBLEM WAS ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ILIAC VEIN. A 14X60/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS SELF EXPANDING WAS ADVANCED FOR TREATMENT OF THE PATIENT PRESSURE SYNDROME. THE STENT WAS DEPLOYED NORMALLY; HOWEVER, AFTER DEPLOYING ABOUT TWO CENTIMETERS, THE STENT EJECTED ITSELF FROM THE DELIVERY SYSTEM AND THE DELIVERY SYSTEM BOUNCED OFF AND RETREATED TO THE SHEATH ORIFICE OF THE VESSEL. IT APPEARED THAT THE STENT WAS NOT FULLY OPENED. ANGIOGRAPHY REVEALED THAT THE ANTERIOR PORTION OF THE STENT WAS APPOSED TO THE VESSEL WALL WHILE THE POSTERIOR HALF WAS NOT, AND A BLOCKAGE HAD FORMED IN THE LUMEN CAUSING CONTRAST RETENTION. AFTER POST-DILATATION, RADIOGRAPHY SHOWED IMPROVEMENT IN FLOW RATE AND STAGNATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21742873 ↗
• InjurySep 27, 2024Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CENTRAL VEIN OF THE SUPERIOR VENA CAVA. A STENT WAS ORIGINALLY PLACED IN THE INTENDED LOCATION, HOWEVER IT SLIPPED INTO THE ATRIUM. A 20FR SHEATH WAS PLACED IN THE FEMORAL VEIN, AND A SNARE WAS USED WITH GUIDEWIRE. THE GUIDEWIRE CROSSED THE STENT STRUCTS AND THEN THE SNARE GRABBED THE GUIDEWIRE AND PULLED THE STENT INTO THE SHEATH, AND THEN REMOVED. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321351 ↗
• MalfunctionNov 15, 2023Failure to Advance; Activation, Positioning or Separation Problem; Failure to Advance; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIALLY DEPLOYED OCCURRED. A BALLOON ANGIOPLASTY WAS PERFORMED ON THE LOWER LIMB. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED ILIAC VEIN. PRE-DILATATION WAS PERFORMED WITH A NON-BOSTON SCIENTIFIC (BSC) BALLOON AND A 14X60/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, ANGIOGRAPHY SHOWED THE TIP OF THE STENT WAS EXPOSED AND PARTIALLY DEPLOYED. IN ADDITION, THE STENT WAS COMPLETELY RECONSTRAINED DURING WITHDRAWAL. THE PHYSICIAN WAS AFRAID OF DAMAGING THE BLOOD VESSELS, SO THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144627 ↗
• InjuryApr 7, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT STENT SHORTENING OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH ILIAC VEIN COMPRESSION SYNDROME. A 14X60/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED TO TREAT THE STENOSED TARGET LESION. HOWEVER, AFTER DEPLOYMENT, IT WAS NOTED THAT THE STENT WAS SHORTER THAN EXPECTED AND COULD NOT OVERLAP WITH THE PREVIOUSLY PLACED STENT. THE STENT COULD NOT BE REMOVED AS IT HAD ALREADY BEEN IMPLANTED AND ANOTHER 14X60/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702563 ↗
• MalfunctionJan 27, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED. THE PATIENT PRESENTED WITH ILIAC VEIN COMPRESSION SYNDROME. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND MODERATELY TORTUOUS ILIAC VEIN. A 14X60/9FR WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT, BUT IT WAS FOUND THAT THE STENT WAS NOT POSITIONED ACCURATELY INSIDE THE PATIENT FOR THE FIRST TIME. WHEN THE PHYSICIAN RECAPTURED AND RE-DEPLOYED IT, THE STENT COULD NOT BE FULLY DEPLOYED. THE STENT WAS RECONSTRAINED PRIOR REMOVAL OF THE DEVICE. THE PROCEDURE WAS ABORTED AND WILL BE DONE AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252825 ↗
• MalfunctionJan 26, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE PATIENT PRESENTED WITH LOWER LIMB EMBOLISM AND UNDERWENT THROMBECTOMY. THE <50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS LOWER LIMB VEIN. A 14X60/9FR UNI PLUS 75CM WALLSTENT UNI ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE SELECTED SIZE WAS PLACED IN THE PATIENT'S BODY, HOWEVER, THE STENT WAS SHORTER THAN THE ACTUAL SIZE. BEFORE PROCEDURE, THE LENGTH OF THE STENT WAS 60 ACCORDING TO THE EXTERNAL PACKAGING. THE ACTUAL MEASUREMENT OF STENT PROPULSION IN VIVO WAS LESS THAN 60. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247330 ↗
• InjuryJun 8, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT STENT PROFILE PROBLEM OCCURRED. THE 70% TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT INNOMINATE VEIN. A 14X60/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS FOUND OUT THAT THERE MIGHT BE A FLAW ON THE TIP PART OF THE STENT WHILE IT WAS RELEASED. THE PHYSICIAN USED A BALLOON TO SOLVE THE ISSUE AND THE STENT WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633689 ↗
• MalfunctionJul 20, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE POST-DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 75 CM, 14X60/9FR WALLSTENT ENDOPROSTHESIS STENT WAS PLACED. AFTER USING A 14MM BALLOON CATHETER FOR POST-DILATATION, THE DISTAL END OF THE STENT WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10296400 ↗
• InjuryFeb 27, 2020Defective Device; Migration; Defective Device; Migration

  IT WAS REPORTED THAT STENT MIGRATION AND STENT FORESHORTENING WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE STENOSED ILIAC VEIN. A 14X60/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER DEPLOYMENT, THE STENT WAS FOUND MOVED AND SHORTENED. THE PHYSICIAN DEPLOYED ANOTHER OF THE SAME DEVICE TO FIX THE ISSUE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9764099 ↗