LIFESTENT® 5F061503CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741120206), received between Dec 27, 2018 and Apr 27, 2026 — classified as 6 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Break; Difficult to Remove; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING LIFESTENT. DURING PROCEDURE IN THE COMMON FEMORAL ARTERY, THE STENT TIP BROKE OFF AFTER STENT DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24996804 ↗
• MalfunctionNov 17, 2025Break; Break

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT VASCULAR STENT VIA CONTRALATERAL APPROACH. DURING PROCEDURE, THE STENT DEPLOYED WITH NO ISSUES. WHEN THE DOCTOR WAS REMOVING THE STENT, THE NOSE CONE ON THE DELIVERY SYSTEM BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566848 ↗
• MalfunctionJul 2, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTENT VASCULAR STENT IN CONTRALATERAL, RIGHT COMMON FEMORAL ARTERY, THE STENT ALLEGEDLY FAILED TO EXPAND FULLY. FURTHER, THE STENT WAS ALLEGEDLY TWISTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381544 ↗
• MalfunctionApr 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE UNLOCK BUTTON WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21846647 ↗
• InjuryMar 27, 2025Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT POST A STENT PLACEMENT PROCEDURE IN THE RIGHT FEMORAL ARTERY, THE TIP OF THE DEVICE ALLEGEDLY BROKE OFF DURING PROCEDURE INTERVENTION. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY COLLAPSED ON ITSELF. REPORTEDLY, THE PATIENT HAD A CUTDOWN PROCEDURE, EXPLORATION AND BYPASS. THE CURRENT STATUS OF THE PATIENT IS STABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21705640 ↗
• MalfunctionMar 11, 2025Break; Break

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY CAME OFF PRIOR TO PUTTING IT THROUGH THE SHEATH AND INTO THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580439 ↗
• InjuryNov 6, 2024Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE CALCIFIED SUPERFICIAL FEMORAL ARTERY VIA THE LEFT COMMON FEMORAL ARTERY CROSSOVER APPROACH, THE STENT ALLEGEDLY SHEARED OFF AND STAYED INSIDE THE PATIENT'S BODY. IT WAS FURTHER REPORTED THAT THE PIECE OF THE DELIVERY SYSTEM THAT WAS LEFT INSIDE THE PATIENT'S BODY WAS UNABLE TO BE REMOVED PERCUTANEOUSLY. REPORTEDLY, THE PIECE THAT WAS LEFT INSIDE THE PATIENT'S BODY WAS REMOVED BY AN OPEN SURGICAL PROCEDURE. THE PATIENT IS REPORTED TO BE STABLE NOW.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20618037 ↗
• MalfunctionJun 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ON THE CATHETER ALLEGEDLY DOES NOT MATCH THE LABELLING OF THE BOX. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525810 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THE DEPLOYMENT MECHANISM OF THE DEVICE ALLEGEDLY BROKE DURING DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069297 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEPLOYMENT MECHANISM OF THE DEVICE ALLEGEDLY BROKE DURING DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069296 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEPLOYMENT MECHANISM OF THE DEVICE ALLEGEDLY BROKE DURING DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069271 ↗
• MalfunctionDec 21, 2023Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE RIGHT POPLITEAL ARTERY VIA GROIN ACCESS, THE STENT TIP WAS ALLEGEDLY FRACTURED WHILE RETRIEVING. IT WAS FURTHER REPORTED THAT TIP MIGRATED DOWN THE WIRE AND LODGED IN THE DELIVERED STENT. REPORTEDLY, COVERED STENT WAS TRAPPED THE FRACTURED STENT DELIVERY TIP AND REMOVED FROM THE LUMEN OF THE ARTERY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370761 ↗
• MalfunctionDec 1, 2023Break; Positioning Failure; Difficult to Remove; Break; Positioning Failure; Difficult to Remove

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE TO TREAT SUPERFICIAL FEMORAL ARTERIAL OCCLUSION VIA RIGHT COMMON FEMORAL ARTERY ACCESS AND OVER THE LEFT SUPERFICIAL FEMORAL ARTERY, THE WHEEL WIRE WASN'T CONNECTED TO THE INNER SHEATH. SO, AS THEY WERE SPINNING THE WHEEL, THE STENT ALLEGEDLY WOULDN'T DEPLOY. IT WAS FURTHER REPORTED THAT UPON REMOVAL, ONLY THE OUTER SHEATH INCLUDING HANDLE ALLEGEDLY CAME OUT; THEN THE INNER SHEATH INCLUDING NON-DEPLOYED STENT WERE REMOVED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18244645 ↗
• MalfunctionOct 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL ARTERY VIA LEFT COMMON FEMORAL, THE STENT ALLEGEDLY FRACTURED IMMEDIATELY AFTER DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17921087 ↗
• MalfunctionJun 20, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY MANGLED AND ONLY REACHED SEVENTY MILLIMETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17165015 ↗
• InjuryApr 21, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN SUPERFICIAL FEMORAL ARTERY THROUGH FEMORAL ACCESS, THE DISTAL TIP OF THE CATHETER DELIVERY SYSTEM WAS ALLEGEDLY DETACHED WITHIN THE SUPERFICIAL FEMORAL ARTERY. IT WAS FURTHER REPORTED THAT SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO SNARE THE DISTAL TIP THROUGH THE FEMORAL ACCESS. FURTHERMORE, THE PATIENT HAD UNDERGONE A SURGICAL BYPASS. REPORTEDLY, AFTER THE DELIVERY WAS REMOVED A SLIGHT BENT WAS FOUND ON THE DISTAL PART OF THE CATHETER. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16783532 ↗
• MalfunctionMar 4, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN LEFT LOWER EXTREMITY FOR CALCIFIED CHRONIC TOTAL OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY, THE GUIDEWIRE WAS ALLEGEDLY STIFF AND UNABLE TO CROSS LESION. PATIENT WAS REPORTED TO BE 76 YEARS FEMALE SUFFERED BY LEG SWELLING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483322 ↗
• MalfunctionJul 14, 2020Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED MALFUNCTION INDICATED THAT MODEL 5F061503CS VASCULAR STENT SYSTEM ALLEGEDLY EXPERIENCED A MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT INJURY THE MALE PATIENT WAS (B)(6) YEARS OLD WITH (B)(6) LBS WEIGHT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10271287 ↗
• InjuryOct 16, 2019Fracture; Fracture

  IT WAS REPORTED THAT SOME TIME POST STENT PLACEMENT THE STENT ALLEGEDLY FRACTURED AND A PSEUDO ANEURYSM WAS IDENTIFIED. REPORTEDLY, THE PATIENT ALLEGEDLY DEVELOPED COMPARTMENT SYNDROME AND A FASCIOTOMY AND STENT REPAIR WERE PERFORMED. THERE WAS NO REPORTED PATIENT INJURY POST STENT REPAIR PROCEDURE.

  Patient problems: Injury

  MAUDE report 9200266 ↗
• MalfunctionOct 14, 2019Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 5F061503CS VASCULAR STENT ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT WAS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9189113 ↗
• InjuryFeb 5, 2019Break; Positioning Failure; Difficult to Remove; Detachment of Device or Device Component; Break; Positioning Failure; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN A CALCIFIED SFA VIA A CONTRALATERAL APPROACH, THE TIP OF THE DEVICE ALLEGEDLY BROKE DURING SUCCESSFUL DEPLOYMENT. IT WAS FURTHER REPORTED THAT A NEW ACCESS SITE WAS MADE DISTALLY TO REMOVE THE BROKEN TIP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8305861 ↗
• InjuryDec 27, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY ONE MONTH POST ANGIOPLASTY PROCEDURE IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON, THE PATIENT HAD TWO VASCULAR STENTS PLACED IN THE RIGHT SFA FOR TOTAL OCCLUSION. APPROXIMATELY ONE WEEK POST VASCULAR STENT PLACEMENT, THE PATIENT UNDERWENT RIGHT BELOW THE KNEE AMPUTATION DUE TO DRY GANGRENE AND CRITICAL LIMB ISCHEMIA. THE VASCULAR STENTS WERE STENOSED AT THE TIME OF THE AMPUTATION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Stenosis

  MAUDE report 8201147 ↗