WALLSTENT® Endoprosthesis H965404520Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729204145), received between Nov 23, 2021 and Jan 15, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Wrong Label” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT DEVICE SIZING DID NOT ALIGN WITH THE BOX LABEL. A 22X70/10 WALLSTENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE WALLSTENT SIZING DID NOT MATCH THE DIMENSIONS INDICATED ON THE BOX LABEL AND CHOSE TO REMOVE THE STENT INSTEAD OF DEPLOYING IT. AFTER REMOVAL, THE LAB DEPLOYED THE STENT ON THE TABLE TO ASSESS ITS ACTUAL SIZE AND DETERMINED THAT THE SIZING DID NOT ALIGN WITH THE MEASUREMENTS PROVIDED ON THE BOX. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164052 ↗
• MalfunctionJan 15, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT STENT SIZE WAS NOT ACCURATE AS THE LABEL. TWO 75CM 22X70/10F WALLSTENT ENDOPROSTHESIS STENTS WERE USED FOR TREATMENT. HOWEVER, THE PHYSICIAN FELT THAT THE STENT WAS TOO LONG AND WAS NOT ACCURATELY SAME SIZE AS THE LABEL ON THE BOX. THE STENT WAS RETRACTED AND REMOVED FROM THE PATIENT'S BODY. THE DEVICE WAS THEN DEPLOYED ON THE TABLE TO DETERMINE THE SIZE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164036 ↗
• InjuryNov 15, 2023Mechanical Problem; Premature Activation; Material Deformation; Mechanical Problem; Premature Activation; Material Deformation

  IT WAS REPORTED THAT THE STENT WAS DAMAGED DURING EXPANSION AND REQUIRED AN ADDITIONAL DEVICE. THE APPROXIMATELY 70%-80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED SUPERIOR VENA CAVA. A 22X70/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED TO TREAT THE LESION. HOWEVER, AFTER THE STENT ENTERED THE VASCULAR SHEATH, THE DEVICE FAILED TO COVER THE LESION AND WAS STUCK ON THE OUTER SHEATH DURING DEPLOYMENT. THIS RESULTS IN STENT BEING DAMAGED AND CHANGING OF PUNCTURE POINT. THE DEVICE WAS SIMPLY PULLED OUT ALONG WITH THE OUTER SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS SUPERIOR VENA CAVA. HOWEVER, DURING DEPLOYMENT, THE SHEATH WAS PUNCTURED. THE DEVICE WAS RECONSTRAINED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141616 ↗
• MalfunctionJun 30, 2023Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT OCCURRED. THE PATIENT PRESENTED WITH MAY THURNER SYNDROME. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ILIAC VEIN. A 22X70/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. UPON DEPLOYMENT ATTEMPTS, ONLY HALF OF THE STENT WAS DEPLOYED AND WOULD NOT GO ANY FURTHER. IT WAS NOTED THAT THE DEVICE WAS STUCK AND WAS NOT RECONSTRAINED DURING REMOVAL. THERE WAS SOME INITIAL RESISTANCE WHILE GETTING THE DISTAL STRUTS OFF OF THE VESSEL AND WHILE THE STENT WAS IN THE SHEATH BEING REMOVED. THE DEVICE WAS REMOVED INTACT, AND THE GUIDEWIRE WAS ABLE TO BE REMOVED FROM THE STENT ONCE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW WALLSTENT AND WAS IMPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239261 ↗
• MalfunctionMay 18, 2023Positioning Failure; Positioning Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25-APR-2023. IT WAS REPORTED THAT STENT DEPLOYMENT FAILURE OCCURRED. A 22X70/10FR 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED TO TREAT THE LESION. HOWEVER, AFTER POSITIONING, THE STENT WOULD NOT RELEASE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED AND WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956971 ↗
• MalfunctionAug 9, 2022Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15-JUL-2022. IT WAS REPORTED THAT ADVANCING DIFFICULTY WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE TRACHEAL BRONCHUS. A 22X70/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT COULD NOT BE ADVANCED INTO THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT PARTIAL DEPLOYMENT AND STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15192939 ↗
• InjuryNov 23, 2021Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. AFTER INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMATION, A 22X70/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS DEPLOYED FOR TREATMENT. HOWEVER, AFTER BALLOON DILATION, THE STENT SLIGHTLY MIGRATED DOWN TOWARDS THE COMMON ILIAC. A SECOND STENT WAS DEPLOYED TO COVER THE WHOLE AREA AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865092 ↗