Pulsar-18 T3 4/40/135Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640130446779), received between Nov 30, 2023 and Aug 20, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (3 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 Failure3
- Fracture1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50339853 ↗MalfunctionMar 24, 2026Activation Failure
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION IN A MILDLY TORTUOUS PART OF THE DISTAL TIBIOPERONEAL TRUNK. THE STENT WOULD NOT DEPLOY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24680239 ↗MalfunctionMar 27, 2025Fracture; Fracture
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (85 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS MID POPLITEAL ARTERY. DURING THE PROCEDURE, BEFORE RELEASING THE STENT, IT WAS NOTICED THAT THE TIP HAD SEPARATED FROM THE DELIVERY SYSTEM. THE SEPARATED TIP WAS DECIDED TO BE LEFT IN THE PATIENT. NO ISSUES WITH BLOOD FLOW SO FAR. THE PROCEDURE WAS COMPLETED BY USING ANOTHER PULSAR-18 T3. AFTER ADDITIONAL COMMUNICATION WITH THE LOCAL STAFF, IT COULD BE CONFIRMED THAT THE STENT WAS PARTIALLY RELEASED OUTSIDE OF THE PATIENT AFTER WITHDRAWAL TO CONFIRM THAT ONLY THE TIP OF THE DEVICE REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 21710980 ↗MalfunctionAug 8, 2024Activation Failure; Activation Failure
A PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE WAS ADVANCED TO THE LESION, BUT THE STENT COULD NOT BE RELEASED. THE DEVICE AND THE WIRE WERE WITHDRAWN AND ANOTHER STENT WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19944969 ↗MalfunctionNov 30, 2023Material Deformation; Material Deformation
A PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. UPON OPENING THE BOX, IT WAS NOTICED THAT THE STENT WAS DAMAGED. THEREFORE, IT WAS NOT INSERTED INTO THE PATIENT, AND ANOTHER PULSAR-18 T3 WAS USED SUCCESSFULLY FOR THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18243203 ↗
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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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