Pulsar-18 T3 5/200/135Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640130446946), received between Feb 20, 2020 and Jan 7, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Failure to Advance

  THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE PROXIMAL SFA. THE DEVICE COULD NOT PASS THE PRE-DILATED LESION. A CUTTING BALLOON WAS USED FOR ADDITIONAL PREPARATION. THEN ANOTHER PULSAR-18 T3 WAS IMPLANTED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987105 ↗
• MalfunctionMay 15, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER PRE-DILATATION, THE PULSAR-18 T3 WAS INSERTED BUT COULD NOT PASS THE LESION. THE DEVICE WAS WITHDRAWN BUT THE TIP OF THE DELIVERY SYSTEM WAS FOUND DAMAGED. A SHOCKWAVE BALLOON WAS USED, AND ANOTHER STENT WAS IMPLANTED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028350 ↗
• MalfunctionApr 3, 2025Material Deformation; Material Deformation

  THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (75 PERCENT STENOSIS DEGREE) A SEVERELY TORTUOUS PART OF THE PROXIMAL RIGHT VERTEBRAL ARTERY. AFTER PRE-DILATATION, THE PULSAR-18 WAS DELIVERED TO THE LESION AND RELEASED, BUT THE DISTAL AREA OF THE STENT WAS TWISTED AND SHORTENED AROUND 1 CM. A BALLOON WAS USED TO INFLATE THE TWISTED AREA, BUT THE STENT STRUCTURE WAS DAMAGED. ANOTHER STENT WAS IMPLANTED TO COVER THE DAMAGED AREA AND THE VESSEL WAS IMPROVED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764141 ↗
• MalfunctionSep 19, 2024Fracture; Fracture

  THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT WAS IMPLANTED ON (B)(6) 2024. APPROXIMATELY 7 WEEKS LATER THE PATIENT RETURNED ON (B)(6) 2024 WITH RECURRING SYMPTOMS. UPON FLUOROSCOPIC EXAM THE VESSEL WAS NOTED TO BE RENARROWED AND THE STENT FRACTURED INTO TYPE 3 STENT FRACTURES AND WAS NOTED TO BE SEPARATED INTO 3 PIECES, WITH AREAS OF TYPE 1 ALSO EVIDENT. ANOTHER STENT WAS PLACED ON (B)(6) 2024 AND THIS PULSAR REMAINED IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 20258518 ↗
• MalfunctionDec 15, 2022Premature Activation; Premature Activation

  A PULSAR-18 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE SFA. THE PULSAR-18 T3 WAS INTRODUCED OVER A V18 BSX WIRE BUT COULD NOT PASS THE HEMOSTATIC VALVE OF THE 4 FRENCH CORDIS SHEATH. SOME FORCE WAS NEEDED WHEN THE STENT DEPLOYED PARTIALLY. THE SDS SYSTEM COULD BE WITHDRAWN OUT OF THE SHEATH WITHOUT ANY PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988040 ↗
• MalfunctionFeb 20, 2020Fracture; Fracture

  A PULSAR-18 T3 STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MILDLY CALCIFIED LESION (30-40 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS SFA. AFTER PLACING AND DEPLOYMENT OF THE STENT IN THE TARGET LESION, THE DEVICE WAS EASILY REMOVED. AFTER WITHDRAWAL IT WAS DETECTED THAT THE INNER SHAFT WAS SEPARATED FROM THE REST OF THE SYSTEM ON THE GUIDE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9735231 ↗