LIFESTENT® 5F071003CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741120343), received between Jun 1, 2022 and Jul 27, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Break; Detachment of Device or Device Component; Difficult to Advance

  On (b)(6)2026, a patient underwent stent placement procedure using a Lifestent device via common femoral artery in the right groin. It was reported that the tip of the delivery catheter broke on the stent and the two hollow outer sheaths broke. It was further reported that the physician tried snaring one of the two pieces which further migrated both distally. One segment parked in a collateral. The other piece was parked with a coronary stent in the profunda which remained patent. However, the current condition of the patient is unknown.

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

  MAUDE report 50020952 ↗
• MalfunctionSep 30, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT 5F VASCULAR STENT. DURING THE PROCEDURE, IT WAS REPORTED THAT LIFESTENT ALLEGEDLY DID NOT EXPAND TO ITS FULL INTENDED LENGTH THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23177733 ↗
• MalfunctionAug 6, 2025Packaging Problem; Packaging Problem

  A PATIENT WAS PREPPED FOR A STENT PLACEMENT PROCEDURE USING THE LIFESTENT 5F VASCULAR STENT. IT WAS REPORTED THAT PRIOR TO STENT PLACEMENT PROCEDURE, THE DEVICES ALLEGEDLY DAMAGED INSIDE THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726491 ↗
• InjuryApr 9, 2025Break; Migration or Expulsion of Device; Detachment of Device or Device Component; Break; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY BROKE OFF. IT WAS FURTHER REPORTED THAT THE BROKEN FRAGMENT ALLEGEDLY MIGRATED TO THE ARTERY. FURTHERMORE, AN OPEN CUTDOWN WAS CARRIED OUT AND THE FRAGMENT RETRIEVED. THE CURRENT STATUS OF THE PATIENT IS STABLE NOW.

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

  MAUDE report 21804407 ↗
• InjuryJan 16, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE RIGHT LOWER EXTREMITY ANGIOGRAM, THE PIECE OF THE STENT DEPLOYMENT SYSTEM BROKE OFF AND REMAINED IN THE ARTERY. IT WAS FURTHER REPORTED THAT AN OPEN CUTDOWN WAS CARRIED OUT AND THE FRAGMENT RETRIEVED. THE CURRENT STATUS OF THE PATIENT IS STABLE.

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

  MAUDE report 21165634 ↗
• InjuryDec 29, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN LEFT COMMON FEMORAL ARTERY, THE TIP OF THE STENT DEVELOPMENT SYSTEM ALLEGEDLY BROKE OFF AND BECAME LODGED INSIDE THE BLOOD VESSEL. IT WAS ALSO REPORTED THAT SNARES WERE USED TO TRY AND RETRIEVE THE CATHETER FRAGMENTS BUT WERE UNSUCCESSFUL. AN OPEN PROCEDURE INVOLVES CUTTING THE ARTERY TO VISUALIZE AND REMOVE CATHETER PIECES. THE PATIENT¿S CURRENT STATUS IS UNKNOWN.

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

  MAUDE report 21032777 ↗
• InjuryNov 23, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE TIP OF THE DELIVERY SYSTEM ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT THE BROKEN PART OF THE DEVICE CANNOT BE SNARED OUT' THEREFORE, THE PATIENT HAD TO HAVE ADDITIONAL MEDICAL INTERVENTION WITH A BYPASS TO REMOVE THE TIP OF THE CATHETER. THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 20766341 ↗
• InjuryMay 23, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY VIA THE COMMON FEMORAL ACCESS, THE STENT DEPLOYMENT SYSTEM ALLEGEDLY BROKE INTO TWO PIECE INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT ONE BROKEN PIECE WAS REMOVED USING A SNARE AND A STENT WAS PLACED TO TRAP THE OTHER PIECE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19379557 ↗
• MalfunctionJun 1, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH COMMON FEMORAL ARTERY OVER CROSS OVER APPROACH OF A CALCIFIED AND TORTUOUS VESSEL, THE NOSE CONE AND DISTAL PORTION OF THE STENT DELIVERY SYSTEM ALLEGEDLY BROKE OFF IN THE PATIENT. IT WAS FURTHER REPORTED THAT ANOTHER STENT WAS PLACED IN SUPERFICIAL FEMORAL ARTERY TO TRAP THE BROKEN PIECE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565416 ↗