Pulsar-18 T3 7/30/135Recalls & 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
- 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 07640130447066), received between Nov 2, 2020 and Feb 27, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2025Fracture; Fracture
DURING AN ANEURYSM INTERVENTION, IT WAS ATTEMPTED TO TREAT A DISSECTION IN THE HEPATIC ARTERY WITH THE PULSAR-18 T3, AWARE OF OFF-LABEL USE. THE DEVICE WAS PLACED INTO THE DISSECTED VESSEL AND THE STENT WAS RELEASED. WHEN PULLING OUT THE DELIVERY SYSTEM, IT WAS NOTICED ON THE ANGIOGRAM SCREEN THAT ONLY THE PROXIMAL MARKER MOVED. THE DISTAL MARKER REMAINED AT ITS PLACE. OUTSIDE IT WAS REALIZED THAT THE SYSTEM WAS OBVIOUSLY BROKEN.
Patient problems: Foreign Body In Patient
MAUDE report 21481176 ↗MalfunctionNov 2, 2020Fracture; Fracture
A PULSAR-18 T3 STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A CALCIFIED LESION. DURING WITHDRAWAL OF THE DELIVER SYSTEM THE DISTAL PART OF THE RETRACTABLE SHAFT HAS FRACTURED. THE FRACTURED PART COULD BE REMOVED FROM PATIENTS BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10769539 ↗
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- 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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