LIFESTENT® 5F061003CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741120183), received between May 10, 2018 and Apr 27, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 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. IT WAS REPORTED THAT THE STENT TIP BROKE OFF AFTER STENT DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24994434 ↗
• MalfunctionDec 5, 2025Misfire; Misfire

  ON (B)(6) 2025, A PATIENT UNDERWENT STENT GRAFT PLACEMENT PROCEDURE USING LIFE STENT. DURING THE PROCEDURE, THE STENT ALLEGEDLY GOT PARTIALLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23724403 ↗
• MalfunctionNov 13, 2024Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE PRODUCT WAS ALLEGEDLY DAMAGED WHILE RECEIVED AT THE HOSPITAL. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20671244 ↗
• MalfunctionOct 15, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING TO A STENT PLACEMENT PROCEDURE VIA CONTRALATERAL ACCESS, THE STENT ALLEGEDLY DEPLOYED PREMATURELY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612505 ↗
• MalfunctionJun 1, 2022Break; Break

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE CATHETER SHAFT ALLEGEDLY BROKE OFF FROM THE DEPLOYMENT HANDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565269 ↗
• MalfunctionFeb 25, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE DISTAL SFA OF THE LEFT LEG VIA THE RIGHT COMMON FEMORAL ARTERY THROUGH HEAVILY CALCIFIED VESSEL, THE CATHETER OF THE DEVICE ALLEGEDLY BROKE OFF INSIDE THE PATIENT. A SNARE HAD TO BE USED TO REMOVE THE DEVICE OFF THE PATIENT. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY HAD A TWIST IN IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13597031 ↗
• MalfunctionFeb 3, 2022Break

  DURING STENT PLACEMENT OF THE LEFT FEM-POP, THE DEPLOYMENT MECHANISM FRACTURED. DR. THEN SNARED THE MECHANISM, STENT LEFT IN PLACE. PER PHYSICIAN'S NOTE: THE FIRST STENT I USED WAS AT THE ABOVE-KNEE POPLITEAL ARTERY, WHICH WAS A BARD LIFESTENT, 6 X 100. INTERESTINGLY, THE FIRST ATTEMPT AT STENTING FAILED DUE TO MECHANICAL DEVICE FAILURE OF THE STENT DEPLOYMENT MECHANISM. I DID NOT EVEN DEPLOY THE STENT, BUT THE DEPLOYMENT MECHANISM DISLODGED AND FRACTURED AND EMBOLIZED INTO THE SUPERFICIAL FEMORAL ARTERY. JUST BEFORE I EVEN INSERTED THE STENT INTO ANY ATHEROMA OR EVEN ATTEMPTED TO TRAVERSE IT THROUGH ANY LESION, IT HAD INTRINSIC FAILURE. I WAS ABLE TO SUCCESSFULLY SNARE THIS DEVICE AND REMOVE THE ENTIRE DEVICE WITH NO FURTHER FOREIGN BODY NOTED FROM THIS DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13440428 ↗
• MalfunctionJul 23, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A VASCULAR STENT DEPLOYMENT IN THE SFA, USING AN ANTEGRADE APPROACH AND ACCESSING THE LESION THROUGH THE LEFT COMMON FEMORAL ARTERY, THE STENT ALLEGEDLY JUMPED AND WAS IMPLANTED APPROXIMATELY 6CM FROM THE INTENDED PLACEMENT SITE. THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT, AND A SECOND VASCULAR STENT WAS DEPLOYED BUT DURING DEPLOYMENT THE STENT ALSO JUMPED AND WAS IMPLANTED APPROXIMATELY 2CM FROM THE INTENDED PLACEMENT SITE. IT WAS FURTHER REPORTED THAT A THIRD VASCULAR STENT WAS SUCCESSFULLY DEPLOYED AT THE INTENDED PLACEMENT SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7712776 ↗
• MalfunctionJun 21, 2018Break; Positioning Failure; Fracture; Misfire; Break; Positioning Failure; Fracture; Misfire

  IT WAS REPORTED THAT AS FORCE INCREASE WAS FELT DURING DEPLOYMENT, THE VASCULAR STENT ALLEGEDLY PARTIALLY DEPLOYED ABOUT 1/2 CM IN THE POPLITEAL, AND THE SHEATH SYSTEM ALLEGEDLY CAME APART. THEREFORE, THE VASCULAR STENT SYSTEM WAS REMOVED WITHOUT INCIDENT FROM THE PATIENT. REPORTEDLY, THE SHEATH WAS REMOVED AND MANUAL PRESSURE WAS HELD FOR HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7627254 ↗
• MalfunctionMay 10, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT ACCESS WAS GAINED IN THE FEMORAL ARTERY USING A SELDINGER TECHNIQUE. A CONTRALATERAL APPROACH TO THE SFA WAS PERFORMED. THE 10 CM LESION IN THE SFA WAS STENOSED AND CALCIFIED; THEREFORE, AND ATHERECTOMY PROCEDURE WAS PERFORMED IN THE SFA FOLLOWED BY A DRUG COATED BALLOON ANGIOPLASTY. REPORTEDLY, THE DEPLOYMENT SYSTEM WAS EXCHANGED OVER THE .014 GUIDEWIRE FOR A PTA BALLOON POST STENT DILATATION. WHILE ADVANCING THE PTA BALLOON OVER THE GUIDEWIRE, GUIDED FLUOROSCOPY DEMONSTRATED A SEMI LUCENT RADIOPAQUE FOREIGN BODY ON THE GUIDEWIRE, THE SCRUB TECH AND PHYSICIAN PERFORMED A VISUAL INSPECTION OF THE LIFESTENT DEPLOYMENT SYSTEM AND IDENTIFIED A DISTAL TIP ALLEGED DETACHMENT. THE PTA BALLOON WAS EXCHANGE OVER THE GUIDEWIRE FOR AN 11FR SHEATH; A SNARE DEVICE SUCCESSFULLY CAPTURED AND RETRIEVED THE DETACHED DISTAL TIP, AND PTA POSTON DILATATION WAS PERFORMED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7503721 ↗