VENOUS WALLSTENT™ H74912044208070Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729979647), received between Apr 7, 2023 and Nov 3, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Nonstandard Device; Incomplete or Missing Packaging; Defective Device; Wrong Label; Nonstandard Device; Incomplete or Missing Packaging; Defective Device; Wrong Label

  IT WAS REPORTED THAT LABELING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC VEIN. A 20X80X75CM VENOUS WALLSTENT STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT A POTENTIAL INCORRECT STENT WAS INSIDE THE PACKAGE. THE DEVICE WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE STENT FOUND TO BE THE WRONG SIZE DURING IVUS -POST DEPLOYMENT. THE STENT SUFFICIENTLY COVERS THE TARGET LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457559 ↗
• MalfunctionSep 16, 2025Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT HOLES IN THE CATHETER OCCURRED. THE 80% STENOSED TARGET LESION WAS SEVERELY TORTUOUS AND SEVERELY CALCIFIED. A 20X80X75CM VENOUS WALLSTENT WAS SELECTED FOR USE. DURING INSERTION, IT WAS NOTED THAT THERE WERE HOLES IN THE CATHETER AND THE MIDDLE OF THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH A 20 X 80 WALLSTENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063356 ↗
• MalfunctionJul 25, 2025Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02JUL2025. IT WAS REPORTED THAT THE STENT UNABLE TO ADVANCE IN ANATOMY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED VENOUS ARTERY. AFTER PREDILATION, THE STENOSIS WAS 40%. A 20X80X75CM VENOUS WALLSTENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS UNABLE TO ADVANCE IN THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED DAMAGED DISTAL STENT WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22615429 ↗
• MalfunctionMay 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BALLOON WAS STUCK ON THE DISTAL END OF THE STENT, NECESSITATING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC VEIN, WHICH WAS MILDLY TORTUOUS, COMPRESSED, AND CALCIFIED. A 20X80X75CM VENOUS WALLSTENT WAS PLACED BY THE PHYSICIAN TO EXTEND A PREVIOUSLY PLACED STENT IN THE LEFT COMMON ILIAC VEIN. THE PHYSICIAN POST-DILATED THE LESION USING AN 18X4X75 XXL BALLOON CATHETER AND ATTEMPTED TO REPOSITION THE STENT DURING BALLOON INFLATION. HOWEVER, THE BALLOON BECAME STUCK AT THE DISTAL END OF THE WALLSTENT AND WOULD NOT RELEASE. WHEN APPLIED MORE FORCE, THE ENTIRE BALLOON DETACHED FROM THE CATHETER SHAFT. EFFORTS TO SNARE AND REMOVE THE BALLOON WERE UNSUCCESSFUL. THE BALLOON LODGED BETWEEN THE VESSEL WALL AND THE FIRST PLACED WALLSTENT IN THE LEFT COMMON ILIAC VEIN. AFTER UNSUCCESSFUL REMOVAL ATTEMPTS, THE PHYSICIAN DECIDED IT WOULD BE BEST TO LEAVE THE BALLOON CAPTURED BETWEEN THE STENT AND THE VESSEL WALL, AS IT WAS IMMOVABLE, AND THE PATIENT WAS ASYMPTOMATIC FOLLOWING THE PROCEDURE. THE PROCEDURE WAS COMPLETED AND THERE WERE NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19361307 ↗
• MalfunctionApr 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DEVICE INTERACTION WITH ANOTHER DEVICE OCCURRED. THE PATIENT WAS BEING TREATED FOR VENOUS COMPRESSION AND UNDERWENT LEFT COMMON ILIAC VENOUS STENT PLACEMENT WITH BALLOON ANGIOPLASTY. THE 50% OR GREATER STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT COMMON ILIAC ARTERY. AFTER A 20X80X75CM VENOUS WALLSTENT WAS ADVANCED AND FULLY DEPLOYED, A 18-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING SECOND INFLATION AT 5 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED DUE TO CONTACT WITH THE STENT STRUTS. DIFFICULTY REMOVAL OF THE BALLOON THROUGH THE SHEATH WAS ENCOUNTERED AND WHEN THE CATHETER WAS PULLED, THE BALLOON REMAINS ON THE CATHETER. FURTHERMORE, THE PHYSICIAN ACCESSED SUPERIOR TO THE BALLOON AND USED A NON-BSC TO SNARE IN ORDER TO RETRIEVE AND REMOVE THE EXCESS BALLOON THAT WAS LODGED IN THE POPLITEAL VEIN. IT WAS NOTED THAT THE STENT WAS FULLY APPOSED TO THE VESSEL WALL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT CONDITION WAS GOOD POST-PROCEDURE AND WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16703271 ↗