LifeStent® Solo Vascular Stent EX062001CLRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049519004105), received between Jan 26, 2016 and Aug 18, 2016 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2016Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE OF THE MID SFA VIA ANTEGRADE APPROACH, THE OUTER CATHETER OF THE DELIVERY SYSTEM BROKE AND THE VASCULAR STENT COULD NOT BE DEPLOYED. ANOTHER STENT OF THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5885162 ↗
• MalfunctionJul 11, 2016Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE FOR TREATMENT OF AN OCCLUSION IN THE SFA, THE VASCULAR STENT COULD NOT BE DEPLOYED WHILE USING A 0.014" GUIDE WIRE. AFTER THE USAGE OF A 0.035" GUIDE WIRE, THERE WAS NOT ANY DEPLOYMENT ISSUE AND THE STENT COULD BE DEPLOYED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5782190 ↗
• MalfunctionMay 3, 2016Difficult to Remove; Retraction Problem; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE VASCULAR STENT WAS DEPLOYED PROPERLY AT THE TARGET SITE, HOWEVER, THE DELIVERY SYSTEM COULD NOT BE RETRACTED OVER THE GUIDE WIRE. THEREFORE, THE OUTER CATHETER WAS CUT AT THE HANDLE, THE INTRODUCER SHEATH WAS PULLED OFF THE WIRE, AND THEN THE OUTER CATHETER WAS REMOVED TOGETHER WITH THE GUIDE WIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5627151 ↗
• MalfunctionJan 26, 2016Positioning Failure

  IT WAS REPORTED THAT THE VASCULAR STENT COULD NOT BE DEPLOYED IN THE SFA.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5390133 ↗