Pulsar-18 T3 5/150/135Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07640130446922), received between Feb 20, 2020 and Apr 28, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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.

• MalfunctionApr 28, 2026Activation Failure

  THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (95% STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE MID FEMORAL ARTERY. AFTER PRE-DILATATION OF THE LESION, STENT IMPLANTATION WAS PERFORMED. FIRST, A PULSAR-18 T3 5/170/135 STENT WAS IMPLANTED VIA THE SUPERFICIAL FEMORAL ARTERY AND SUCCESSFULLY RELEASED. SUBSEQUENTLY, THE COMPLAINT DEVICE WAS PLACED BUT FAILED TO RELEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015169 ↗
• MalfunctionMar 18, 2025Activation Failure; Activation Failure

  THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF A MID-PART OF A LOWER LIMB ARTERY. AFTER PRE-DILATION, THE PULSAR-18 T3 WAS ADVANCED TO THE LESION AND THE STENT WAS RELEASED, BUT NO STENT WAS VISIBLE AFTER RELEASE. THE DELIVERY SYSTEM TOGETHER WITH THE VASCULAR SHEATH WAS WITHDRAWN, AND IT WAS DETECTED THAT THE STENT IN THE DELIVERY SYSTEM DID NOT UNFOLD. ANOTHER STENT OF SAME MODEL WAS IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633633 ↗
• MalfunctionSep 16, 2024Failure to Advance; Failure to Advance

  A PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (98 PERCENT STENOSIS DEGREE) IN THE SEVERELY TORTUOUS OSTIAL LEFT SFA. A PRE-DILATATION WITH A PASSEO-18 WAS PERFORMED, BUT THE VESSEL IMPROVED VERY LITTLE. THEN IT WAS PLANNED TO IMPLANT THE PULSAR-18 T3, BUT THE LESION COULD NOT BE CROSSED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225496 ↗
• MalfunctionFeb 8, 2023Fracture; Premature Activation; Fracture; Premature Activation

  PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A LONG OCCLUSION OF THE ENTIRE LEFT SFA. AFTER SUCCESSFUL IMPLANTATION OF A PULSAR-18 T3 STENT, IT WAS DECIDED TO USE ANOTHER PULSAR-18 T3 AS AN EXTENSION. DURING INTRODUCTION RESISTANCE WAS FELT AT THE PREVIOUSLY IMPLANTED STENT AND IT COULD NOT BE CROSSED. AFTER WITHDRAWAL, THE TIP OF THE DEVICE WAS DESCRIBED AS SEEMED TO BE MUCH TOO LOOSE AND THE INSTRUMENT WAS NOT USED ANYMORE. (REPORTED UNDER 1028232-2023-00527). THE COMPLAINT INSTRUMENT WAS INTRODUCED THROUGH THE 4F INTRODUCER SHEATH, BUT RESISTANCE WAS FELT AT THE LEVEL OF THE MEDIAL POPLITEAL ARTERY AND COULD NOT ADVANCE ANY FURTHER. AFTER WITHDRAWAL, THE DISTAL END OF THE COMPLAINT INSTRUMENT ALSO SEEMED TO BE MUCH TOO LOOSE. BUT AS THE OUTCOME OF THIS INSTRUMENT WAS COMPARABLE TO THE FIRST COMPLAINT INSTRUMENT, IT WAS DECIDED TO RE-INSERT THE INSTRUMENT. DURING THE RE-INSERTION PHASE, THE COMPLAINT INSTRUMENT BECAME STUCK AGAIN COMPLETELY AND IT WAS IMPOSSIBLE TO WITHDRAW THE DEVICE. THE EXAMINATION REVEALED THAT THE STENT HAS BEEN UNFOLDED (I.E. RELEASED), BOTH INSIDE AND OUTSIDE OF THE INTRODUCER SHEATH AND THE TIP OF THE DEVICE WAS BROKEN OFF. MO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326468 ↗
• MalfunctionFeb 1, 2023Fracture; Fracture

  PULSAR-18 T3 STENT SYSTEMS WERE CHOSEN FOR TREATMENT OF THE SFA. AFTER PREDILATATION AND A SUCCESSFULLY ANTEGRADE PLACEMENT OF A PULSAR-18 T3 STENT SIZE 5/200/135, AN EXTENSION WAS NEEDED. THE COMPLAINT PULSAR-18 T3 WAS ADVANCED THROUGH THE FIRST PLACED STENT, WHEN RESISTANCE WAS FELT. THE STENT WAS WITHDRAWN OUT OF THE PATIENT, AND IT WAS DETECTED THAT THE DISTAL END OF THE CATHETER COULD BE MOVED BACK AND FORTH, SEPARATELY FROM THE SHAFT OF THE SDS. ORIGINALLY REPORTED ON MDR-1028232-2022-06476, BUT WAS ON WRONG LOT NUMBER. THAT REPORT HAS BEEN CLOSED AND REPORTING CORRECT INFORMATION ON THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16281364 ↗
• MalfunctionDec 21, 2022Premature Activation; Premature Activation

  A PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. ACCESS VIA A. POPLITEAL FOR RETROGRADE STENT PLACEMENT OF THE SFA. A 4F SHEATH WAS USED, THE PULSAR-18 T3 WAS INTRODUCED OVER A .018 WIRE. A LOT OF RESISTANCE WAS FELT ADVANCING THE SDS THROUGH THE SHEATH. THE STENT WAS PARTIALLY DEPLOYED INTO THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16020167 ↗
• MalfunctionDec 15, 2022Fracture; Fracture

  PULSAR-18 T3 STENT SYSTEMS WERE CHOSEN FOR TREATMENT OF THE SFA. AFTER PREDILATATION AND A SUCCESSFULLY ANTEGRADE PLACEMENT OF A PULSAR-18 T3 STENT SIZE 5/200/135, AN EXTENSION WAS NEEDED. THE COMPLAINT PULSAR-18 T3 WAS ADVANCED THROUGH THE FIRST PLACED STENT, WHEN RESISTANCE WAS FELT. THE STENT WAS WITHDRAWN OUT OF THE PATIENT, AND IT WAS DETECTED THAT THE DISTAL END OF THE CATHETER COULD BE MOVED BACK AND FORTH, SEPARATELY FROM THE SHAFT OF THE SDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988015 ↗
• MalfunctionFeb 20, 2020Positioning Failure; Positioning Failure

  A PULSAR-18 T3 STENT SYSTEM WAS SELECTED TO TREAT A CALCIFIED LESION IN THE SFA. DESPITE PRESSING THE SAFETY TAB THE WHEEL DID NOT WORK AND THE STENT COULD NOT BE RELEASED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9735073 ↗