LIFESTENT® 5F051703CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741120671), received between Oct 14, 2019 and Mar 3, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Break; Positioning Failure; Difficult to Remove; Activation Failure

  ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE THUMB WHEEL WAS BROKEN, AND THE STENT WOULD NOT DEPLOY. REPORTEDLY, IT GOT STUCK IN THE SHEATH, SO EVERYTHING HAD TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493277 ↗
• InjurySep 26, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA COMMON FEMORAL ARTERY, THE INNER PART OF THE CATHETER WAS LEFT BEHIND IN THE BODY. IT WAS FURTHER REPORTED THAT THE REST OF THE CATHETER WAS NOT REMOVED FROM THE PATIENT. THE USER SNARED THE METAL PIECE OUT AND PUT A STENT TO COVER THE REST OF WHAT COULD NOT BE REMOVED. REPORTEDLY, ADDITIONAL STENT WAS PLACED AND PROCEDURE WAS COMPLETED. THE PATIENT IS STABLE NOW.

  Patient problems: Foreign Body In Patient

  MAUDE report 20308233 ↗
• MalfunctionApr 11, 2024Break; Positioning Failure; Detachment of Device or Device Component; Break; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL FEMORAL ACCESS, THE STENT WAS ALLEGEDLY BROKEN AT SHAFT WHILE PULLING BACK INSIDE THE SHEATH AND THROUGH HEMOSTATIC VALVE. THE PROCEDURE COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085994 ↗
• MalfunctionApr 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 THE DISTAL TIP WAS REMOVED WITH A SNARE VIA THE FEMORAL ACCESS. REPORTEDLY, AFTER THE DELIVERY WAS REMOVED A SLIGHT BENT WAS FOUND ON THE DISTAL PART OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16783528 ↗
• MalfunctionMar 30, 2022Break; Difficult or Delayed Positioning; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult or Delayed Positioning; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT DEPLOYMENT SYSTEM TIP WAS ALLEGEDLY BROKE AND DETACHED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY REMOVED WITH SOME DIFFICULTY. REPORTEDLY, THE STENT EVENTUALLY WAS DEPLOYED, ALTHOUGH THERE WAS SLIGHT DIFFICULTY. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13947359 ↗
• MalfunctionFeb 13, 2020Structural Problem; Activation, Positioning or Separation Problem

  UPON SURGEON DEPLOYING STENT, SHE NOTED A SMALL PIECE OF DEVICE SEPARATED FROM THE IMPLANT DELIVERY SYSTEM ON X-RAY, SURGEON INSPECTED STENT DEPLOYING DEVICE AND DIDN'T NOTE ANYTHING UNUSUAL BUT SEEMED TO THINK THAT IT COULD BE SOMETHING FROM THE STENT DEVICE, SHE THEN HAD TO DEPLOY ADDITIONAL STENTS TO TRAP THE PIECE AGAINST THE WALL OF ARTERY. BARD REP WAS PRESENT AND AWARE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9705846 ↗
• MalfunctionFeb 11, 2020Difficult to Remove; Device-Device Incompatibility; Difficult to Advance; Difficult to Remove; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT AFTER DIFFICULTY ADVANCING THE DELIVERY SYSTEM OVER THE GUIDEWIRE, THROUGH THE INTRODUCER SHEATH AND THROUGH THE TRACKING VESSEL, THE STENT SUCCESSFULLY DEPLOYED IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY; HOWEVER, A SEGMENT OF THE DELIVERY SYSTEM THEN ALLEGEDLY BROKE AND DETACHED WITHIN THE PATIENT. REPORTEDLY, THE DELIVERY SYSTEM WAS REMOVED WITH DIFFICULTY AND UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE SEGMENT; THEREFORE, THE HEALTHCARE PROVIDER (HCP) IMPLANTED TWO ADDITIONAL STENTS OF A DIFFERENT MANUFACTURER OVER THE SAME ACCESS SITE TO SECURE THE SEGMENT TO THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9693775 ↗
• MalfunctionOct 14, 2019Positioning Failure; Difficult to Remove; Misfire; Device-Device Incompatibility; Positioning Failure; Difficult to Remove; Misfire; Device-Device Incompatibility

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 5F051703CS VASCULAR STENT SYSTEM ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY, MISFIRE, DEVICE-DEVICE INCOMPATIBILITY, AND DIFFICULTY ADVANCING. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCE. THE ONE PATIENT WAS REPORTED AS A 58 YEAR OLD MALE OF UNKNOWN WEIGHT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187064 ↗