LifeStent® Solo Vascular Stent EX072003CLRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04049519004402), received between Oct 27, 2015 and May 4, 2026 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Difficult to Remove; Misfire

  ON (B)(6) 2026, A 65-YEAR-OLD FEMALE PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTENT. THE STENT BEGAN TO DEPLOY BUT MALFUNCTIONED AFTER APPROXIMATELY TWO CM HAD BEEN UNCOVERED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25065646 ↗
• MalfunctionFeb 25, 2026Failure to Advance; Material Deformation

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT SOLO STENT. DURING THE PROCEDURE, THE STENT FAILED TO ADVANCE PAST THE LESION. IT WAS FURTHER REPORTED THAT WHEN THE DELIVERY SYSTEM WAS INSERTED INTO THE ARTERY, THE PHYSICIAN FELT RESISTANCE AND SUBSEQUENTLY REMOVED THE SYSTEM. A DEFECT WAS OBSERVED ON THE SHAFT OF THE DELIVERY SYSTEM, WHICH APPEARED CRUMPLED ALONG THE SHAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24440754 ↗
• MalfunctionOct 22, 2020Misfire; Malposition of Device; Material Deformation; Misfire; Malposition of Device; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL EX072003CL VASCULAR STENT ALLEGEDLY EXPERIENCED MALPOSITION OF DEVICE, MATERIAL DEFORMATION AND MISFIRE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE 70 YEARS OLD MALE PATIENT WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722804 ↗
• MalfunctionJan 9, 2020Difficult to Remove; Material Deformation; Positioning Problem; Difficult to Remove; Material Deformation; Positioning Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL EX072003CL VASCULAR STENT ALLEGEDLY EXPERIENCED A POSITIONING ISSUE AND DIFFICULTY TO REMOVE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE AGE AND WEIGHT OF THE FEMALE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9570381 ↗
• MalfunctionOct 23, 2018Premature Activation; Misfire; Difficult to Advance; Premature Activation; Misfire; Difficult to Advance

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE FOR ARTHERECTOMY, RESISTANCE WAS ALLEGEDLY FELT WHILE TRACKING THE STENT TO THE INTENDED PLACEMENT SITE. IT WAS FURTHER REPORTED THAT CLICKING SOUNDS WERE HEARD AND THE STENT WAS STILL INSIDE THE SHEATH. UPON REMOVAL OF THE DELIVERY SYSTEM, THE STENT ALLEGEDLY PREMATURELY DEPLOYED ON THE TABLE. ANOTHER DEVICE WAS REPORTEDLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7996028 ↗
• MalfunctionAug 9, 2018Break; Positioning Failure; Misfire; Material Deformation; Break; Positioning Failure; Misfire; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO DEPLOY. THE SYSTEM WAS REMOVED AND ANOTHER PRODUCT WAS USED FOR TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7770913 ↗
• InjuryFeb 7, 2018Fracture; Material Torqued; Material Twisted/Bent; Fracture; Material Torqued; Material Twisted/Bent

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST STENT PLACEMENT IN THE POPLITEAL ARTERY, THE STENT ALLEGEDLY HAD MULTIPLE FRACTURES. IT WAS FURTHER REPORTED, THE PATIENT RETURNED WITH REOCCURRING SYMPTOMS (CLAUDICATION) WHICH MAY HAVE REQUIRED MEDICAL INTERVENTION. CURRENT PATIENT STATUS IS UNKNOWN.

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

  MAUDE report 7249160 ↗
• InjuryMay 16, 2017Fracture; Occlusion Within Device; Obstruction of Flow; Fracture; Occlusion Within Device; Obstruction of Flow

  IT WAS REPORTED THAT 13 MONTHS POST PTA AND PLACEMENT OF TWO STENTS IN OVERLAPPING TECHNIQUE IN THE PROXIMAL 1/3 OF THE SFA FOR TREATMENT OF A 100 % STENOSIS OF 240 MM LENGTH, AN IN-STENT RESTENOSIS WAS DETECTED. REVASCULARIZATION WAS PERFORMED FOR PATIENT TREATMENT. ADDITIONALLY, DURING A 12 MONTHS FOLLOW UP, A STENT FRACTURE WAS REPORTED. HOWEVER, NO ADDITIONAL TREATMENT WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; Stenosis

  MAUDE report 6569286 ↗
• InjuryMay 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE VASCULAR STENT (7 X 200 MM) WAS IMPLANTED IN THE LEFT SFA. DURING POST-DILATION WITH A 200 MM BALLOON, IT WAS NOTICED THAT THE LENGTH OF THE VASCULAR STENT WAS HALF OF THE LABELED SIZE. TWO ADDITIONAL STENTS WERE IMPLANTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6566998 ↗
• MalfunctionMar 28, 2017Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST STENT PLACEMENT IN THE STENOSED SFA, A STENT FRACTURE WAS DETECTED. REPORTEDLY, THERE WERE NO DIFFICULTIES DURING THE INTERVENTION. THE LESION WAS PRE DILATED WITH A 4 X 120 MM AND A 5 X 120 MM BALLOON. ALSO, THE STENT WAS POST DILATED WITH A 6MM BALLOON. THE INITIAL STENT PLACEMENT PROCEDURE WAS CONCLUDED WITH A GOOD RESULT. NO ADDITIONAL INTERVENTION WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6438302 ↗
• MalfunctionDec 27, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN A PRE-DILATED SFA LESION VIA COMMON FEMORAL ARTERY ACCESS, THE STENT COULD NOT BE DEPLOYED PROPERLY. THE DELIVERY SYSTEM WAS REMOVED AND ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6204655 ↗
• MalfunctionJul 11, 2016Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE PRE-DILATED SFA VIA CFA ACCESS, THE VASCULAR STENT COULD NOT BE DEPLOYED ANY FURTHER AFTER BEING PARTIALLY RELEASED 1 MM. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5782234 ↗
• MalfunctionJul 4, 2016Positioning Failure; Fracture; Premature Activation; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE OF THE SFA, THE STENT PARTIALLY DEPLOYED. THE TRACKING PATH AND TARGET LESION WAS REPORTED TO BE CALCIFIED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Calcium Deposits/Calcification; No Consequences Or Impact To Patient

  MAUDE report 5767931 ↗
• InjuryJun 8, 2016Fracture; Occlusion Within Device; Obstruction of Flow; Material Twisted/Bent; Fracture; Occlusion Within Device; Obstruction of Flow; Material Twisted/Bent

  IT WAS REPORTED THAT 9 MONTHS POST PLACEMENT OF TWO OVERLAPPING STENTS IN THE SFA, THE STENTED SECTION WAS FOUND TO BE RESTENOSED AND POSSIBLY FRACTURED. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS TREATED WITH A MEDICAL THERAPY. THERE WAS NO REPORTED PATIENT INJURY. THIS COMPLAINT ADDRESSES THE PROXIMAL STENT AND CONCERNS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00161.

  Patient problems: No Consequences Or Impact To Patient; Occlusion; Reocclusion

  MAUDE report 5706499 ↗
• MalfunctionFeb 15, 2016Positioning Failure

  IT WAS REPORTED THAT THE VASCULAR STENT COULD NOT BE DEPLOYED DURING THE STENT PLACEMENT PROCEDURE. THE DELIVERY SYSTEM WAS RETRACTED FROM THE LESION SITE WITHOUT ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5436393 ↗
• MalfunctionJan 26, 2016Positioning Failure

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5390132 ↗
• MalfunctionNov 17, 2015Positioning Failure

  IT WAS REPORTED THAT THE VASCULAR STENT COULD NOT BE DEPLOYED IN THE LEFT SFA DURING THE STENT PLACEMENT PROCEDURE. THE DELIVERY SYSTEM WAS RETRACTED WITHOUT ISSUE. ANOTHER STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5230608 ↗
• MalfunctionOct 27, 2015Positioning Failure

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE, THE VASCULAR STENT COULD NOT BE DEPLOYED IN THE SFA. THE DELIVERY SYSTEM WAS RETRACTED WITHOUT ISSUE. ANOTHER VASCULAR STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5180797 ↗