Pulsar-18 T3 6/40/135Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640130446977), received between Nov 4, 2022 and Jan 27, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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 27, 2025Activation Failure; Activation Failure

  THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A SEVERELY TORTUOUS PART OF THE OSTIAL SFA. THE DEVICE WAS ADVANCED TO THE LESION AND THE SAFETY BUTTON WAS CLICKED. THE STENT WAS PARTIALLY RELEASED, AND THE LOCATION COULD NOT BE ADJUSTED. DEVICE AND STENT WERE RETRIEVED AND ANOTHER STENT WAS USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21243150 ↗
• MalfunctionDec 16, 2024Fracture; Premature Activation; Fracture; Premature Activation

  THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE GOT STUCK INSIDE THE 4F INTRODUCER SHEATH AND IT WAS IMPOSSIBLE TO MOVE FORWARD. THE DISTAL PART BROKE AND THE STENT SELF-EXPANDED INSIDE THE INTRODUCER SHEATH. THE DEVICE WAS RETRIEVED TOGETHER WITH THE INTRODUCER SHEATH.

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

  MAUDE report 20944863 ↗
• MalfunctionNov 26, 2024Fracture; Activation Failure; Fracture; Activation Failure

  THE PULSAR-18 T3 STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. THE STENT FAILED TO DETACH ORIGINALLY, CAUGHT ON STRUTS WHEN REMOVING. ANOTHER STENT WAS USED, AND THE INTERVENTION WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780004 ↗
• MalfunctionOct 25, 2023Material Deformation; Material Deformation

  A PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PREDILATED LESION WITH 80 PERCENT STENOSIS DEGREE IN THE POPLITEAL ARTERY. AFTER THE PULSAR-18 T3 WAS DEPLOYED, IT WAS NOTICED THAT THE STENT WAS DEFORMED AT THE DISTAL END. POST-DILATATION WAS PERFORMED. THE STENT REMAINS IN PATIENT. PATIENT WAS DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004683 ↗
• MalfunctionJun 27, 2023Activation Failure; Activation Failure

  THE PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. AN ATTEMPT WAS MADE TO PUSH THE PULSAR-18 T3 OVER THE V18 GUIDEWIRE, BUT IT REMAINED STUCK. DESPITE THE NOTED FRICTION, THE DEVICE WAS PUSHED FURTHER. DURING THIS ATTEMPT, THE STENT WAS PARTIALLY RELEASED. THE DEVICE WAS REMOVED. A SECOND GUIDEWIRE WAS INSERTED INTO THE GUIDEWIRE LUMEN OF ANOTHER PULSAR-18 T3 FROM THE OTHER DIRECTION. AFTERWARDS, THIS PULSAR-18 T3 WAS USED AS USUAL, AND THE STENT WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17214033 ↗
• MalfunctionNov 4, 2022Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  A PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT SYSTEM WAS DIFFICULT TO FLUSH. THE SYSTEM BARELY PASSED OVER THE WIRE. THE STENT COULD NOT BE DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726906 ↗