Pulsar-18 T3 5/60/135Recalls & 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 07640130446885), received between Nov 16, 2023 and Feb 20, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (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
- Activation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2025Activation Failure; Activation Failure
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE AXILLARY ARTERY. THE DEVICE WAS INSERTED THROUGH LEFT ARM FOR A RADIAL APPROACH, BUT THE STENT DID NOT DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21422090 ↗MalfunctionNov 16, 2023Activation Failure; Activation Failure
A PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A 60MM LONG LESION IN A TIBIAL VESSEL. THE STENT WAS UNABLE TO BE DEPLOYED IN THE LESION. SAFETY MECHANISM WAS UNLOCKED, AND THE WHEEL WAS TURNED, BUT THE STENT APPEARS TO BE STUCK ON THE DELIVERY SYSTEM. THE SYSTEM WAS REMOVED FROM THE PATIENT WITH STENT STILL IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18152400 ↗
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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