Pulsar-18 T3 5/60/90Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640130446489), received between Jun 15, 2020 and Nov 9, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2020Mechanical Problem; Mechanical Problem
A PULSAR-18 T3 STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A PRE-DILATED MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS PROXIMAL SFA. AFTER STENT DEPLOYMENT IT WAS NECESSARY TO TAKE OFF THE STENT SYSTEM TOGETHER WITH THE GUIDEWIRE. IT WAS NOTICED THAT THE SHAFT WAS COMPLETELY WRINKLED CATCHING THE GUIDEWIRE. AFTER STRETCHING THE SHAFT IT WAS POSSIBLE TO REMOVE THE GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10813204 ↗MalfunctionJun 15, 2020Fracture; Fracture
A PULSAR-18 T3 STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A CALCIFIED LESION WITH 70 PERCENT STENOSIS DEGREE. AFTER SUCCESSFUL STENT DEPLOYMENT RESISTANCE WAS FELT WHILE IT WAS ATTEMPTED TO REMOVE THE SYSTEM. EVENTUALLY THE DEVICE FRACTURED DURING WITHDRAWAL. ALL DEVICE PARTS WERE REMOVED FROM THE PATIENTS BODY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10155366 ↗
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.
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