Pulsar-18 T3 5/40/135Recalls & 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 07640130446878), received between Jul 20, 2023 and Dec 15, 2025 — classified as 4 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
- Difficult to Remove1
- Failure to Advance1
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.
MalfunctionDec 15, 2025Fracture; Fracture
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. THE CATHETER WAS TORN (~ PROXIMAL 20CM) INSIDE PATIENT. EVERYTHING COULD BE RETRIEVED FROM THE PATIENT. FURTHER INFORMATION IS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23801858 ↗MalfunctionJan 20, 2025Failure to Advance; Failure to Advance
A DISSECTION WAS FOUND IN THE P2 SEGMENT OF THE POPLITEAL ARTERY, WHICH OCCURRED DURING PRE-DILATATION. THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. THE ANGIO SHOWED THAT THE DISSECTION WAS LARGE AND THE VASCULAR MORPHOLOGY WAS RELATIVELY TWISTED, RESULTING IN A LARGE RESISTANCE TO THE STENT DELIVERY. EVENTUALLY, THE STENT COULD NOT REACH THE LESION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21193214 ↗MalfunctionNov 2, 2023Difficult to Remove; Difficult to Remove
A PULSAR-18 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER SUCCESSFUL STENT IMPLANTATION, THE DELIVERY SYSTEM OF THE PULSAR-18 T3 GOT STUCK ON THE GUIDEWIRE. A COMPLETE RETRACTION WAS ONLY POSSIBLE WITH GREAT FORCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18057827 ↗MalfunctionJul 20, 2023Fracture; Fracture
A PULSAR-18 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER SUCCESSFUL STENT IMPLANTATION, WHEN PULLING BACK THE DELIVERY SYSTEM, A PIECE BROKE OFF, BUT COULD BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17363856 ↗
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- 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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