Pulsar-18 T3 5/170/135Recalls & reported problems
Biotronik AG · Class 3 · Implant
All models of Pulsar-18 T3 (52)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130446939), received between Aug 26, 2024 and Feb 20, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Activation Failure1
- Activation Problem1
- Failure to Advance1
- Fracture1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Fracture
THE GUIDEWIRE WAS ADVANCED ACROSS THE LESION TO CONFIRM THAT THE VESSEL DIAMETER WAS APPROXIMATELY 5 MM. THE PULSAR-18 T3 STENT SYSTEM WAS THEN ADVANCED TO THE TARGET LESION AND THE STENT WAS DEPLOYED. DURING WITHDRAWAL OF THE DELIVERY SYSTEM, A FRACTURE OF PART OF THE DELIVERY SYSTEM WAS IDENTIFIED. THE FRACTURED COMPONENT WAS SUCCESSFULLY RETRIEVED AND REMOVED FROM THE BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400795 ↗MalfunctionJan 7, 2026Failure to Advance
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (80% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID SFA. THE DEVICE COULD NOT PASS THE LESION. ANOTHER PULSAR-18 T3 WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987108 ↗MalfunctionDec 8, 2025Activation Failure; Activation Problem; Activation Failure; Activation Problem
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE PROXIMAL SFA. AFTER DELIVERING THE DEVICE TO THE LESION, THE TRIGGER COULD NOT BE MOVED. ANOTHER PULSAR-18 T3 WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23740558 ↗MalfunctionAug 26, 2024Material Deformation; Material Deformation
AFTER PRE-DILATATION, THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT WAS IMPLANTED BUT THE ANGIOGRAPHY THE LENGTH SEEMED TO BE 20MM SHORTER THAN IT SHOULD BE. THE STENT COULD NOT COVER THE LESION. ANOTHER PULSAR-18 T3 STENT WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20065477 ↗
Other STENT, SUPERFICIAL FEMORAL ARTERY devices
- EverFlex™ EVD35-06-150-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 death110 reports
- SUPERA S-60-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY108 reports
- SUPERA S-55-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY88 reports
- LifeStent® Solo Vascular Stent EX062003CLBard Peripheral Vascular, Inc. · STENT, SUPERFICIAL FEMORAL ARTERY80 reports
- BioMimics 3D Vascular Stent System 144700-12Veryan Medical Limited · Stent, Superficial Femoral Artery74 reports
- SUPERA S-50-120-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY55 reports
- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-120-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page