Pulsar-18 T3 6/200/90Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130446649), received between Dec 29, 2021 and Jun 18, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation2
- Activation Failure1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Pain1
- Restenosis1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2025Material Deformation; Material Deformation
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT AND WAS IMPLANTED ON (B)(6) 2024 IN THE MODERATELY TORTUOUS LEFT SFA. ON REPEAT ANGIOGRAM ON (B)(6) 2025 IT WAS NOTED THAT PREVIOUSLY DEPLOYED STENT WAS CRUSHED, AND THE SFA IS TOTALLY OCCLUDED. THE PATIENT IS NOW TREATED MEDICALLY.
Patient problems: Pain; Restenosis
MAUDE report 22285911 ↗MalfunctionJan 5, 2023Activation Failure; Activation Failure
A PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT COULD NOT BE RELEASED. DESPITE HEAVILY TURNING THE WHEEL, NO RELEASE WAS POSSIBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16103762 ↗MalfunctionDec 15, 2022Material Deformation; Material Deformation
A PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS CHOSEN FOR TREATMENT. ACCORDING TO THE PHYSICIAN, THE STENT COULD NOT BE RELEASED CORRECTLY. AFTER DEPLOYMENT, THE STENT WAS ONLY HALF AS LONG AS STATED, SO ANOTHER STENT HAD TO BE PLACED. THE STENT WAS 6MM IN DIAMETER AND SHOULD HAVE BEEN 200MM LONG. THE INTERVENTION WAS SUCCESSFULLY COMPLETED WITH PLACEMENT OF A 2ND STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15986442 ↗MalfunctionDec 29, 2021Failure to Advance; Failure to Advance
A PULSAR 18 T3 PERIPHERAL STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PREDILATED LESION. IT WAS NOT POSSIBLE TO PLACE THE PULSAR 18 T3 STENT AT ITS INTENDED POSITION INSIDE THE TARGET LESION AS IT GOT STUCK INSIDE THE 4F INTRODUCER SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13112551 ↗
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- 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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