LIFESTENT® 5F070403CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741120312), received between Nov 5, 2018 and Jul 28, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Break; Positioning Failure; Break; Positioning Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING LIFESTENT 5F VASCULAR STENT. DURING THE PROCEDURE THE DEPLOYMENT WHEEL ALLEGEDLY BROKE, THUS STENT WAS NOT DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629450 ↗
• InjuryJul 9, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE IN LEFT FEMORAL IPSI LATERAL USING THE LIFESTENT 5F VASCULAR STENT AND DURING THE PROCEDURE THE PART OF THE DELIVERY SYSTEM ALLEGEDLY BROKE OFF. IT WAS FURTHER REPORTED THAT THE BROKEN PIECE WAS ALLEGEDLY RETRIEVED BY USING SNARE, BUT FURTHER FRAGMENTATION OCCURRED. A MEDTRONIC STENT WAS THEN PLACED TO SECURE THE REMAINING PORTION. THE CURRENT STATUS WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22456529 ↗
• MalfunctionMar 15, 2025Positioning Failure; Material Separation; Material Deformation; Positioning Failure; Material Separation; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH COMMON FEMORAL, THE DEVICE ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT STENT WAS ALLEGEDLY SHORTENED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21613370 ↗
• MalfunctionJan 16, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE PART OF THE DELIVERY SYSTEM ALLEGEDLY BROKE OFF INSIDE THE PATIENT'S BODY. REPORTEDLY, THE BROKEN PIECE WAS RETRIEVED BY USING A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 21167266 ↗
• MalfunctionJan 16, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE PART OF THE DELIVERY SYSTEM ALLEGEDLY BROKE OFF. IT WAS FURTHER REPORTED THAT THE BROKEN PIECE WAS ALLEGEDLY RETRIEVED BY USING SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21166096 ↗
• MalfunctionJan 16, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE PART OF THE DELIVERY SYSTEM ALLEGEDLY BROKE OFF. REPORTEDLY, BROKEN PIECE WAS ALLEGEDLY RETRIEVED BY USING SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21165632 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST A STENT PLACEMENT, THE PATIENT ALLEGEDLY HAD ALLERGIC REACTIONS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18132267 ↗
• MalfunctionJul 7, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY PARTIALLY DEPLOYED UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17280464 ↗
• MalfunctionMar 21, 2022Break; Break

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA A RIGHT RADIAL ACCESS THROUGH THE RIGHT ILIAC ARTERY THROUGH A CALCIFIED LESION, PARTS OF THE PRODUCT WAS ALLEGEDLY UNABLE TO BE REMOVED AND WAS LEFT INSIDE THE PATIENT. THE FRACTURED PARTS OF THE DEVICE WAS REMOVED USING A SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838358 ↗
• MalfunctionOct 22, 2020Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 5F070403CS 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 MALE PATIENT WAS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722678 ↗
• MalfunctionOct 14, 2019Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 5F070403CS VASCULAR STENT SYSTEM ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY, A BREAK, AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT WITH NO PATIENT INJURY. THE PATIENT WAS MALE AND THE AGE AND WEIGHT WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187859 ↗
• MalfunctionNov 5, 2018Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE ON THE MID-SFA THROUGH FEMORAL ACCESS, A DAMAGED COMPONENT PREVENTED THE SAFETY LOCK TO MOVE, THEREFORE PREVENTING THE DEPLOYMENT WHEEL TO ROTATE, AND THE STENT ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8040178 ↗