Pulsar-18 T3 6/80/90Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130446595), received between Apr 15, 2020 and Jan 18, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Premature Activation” (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
- Premature Activation2
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 18, 2024Premature Activation; Premature Activation
THE PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT BUT COULD NOT BE INTRODUCED INTO THE INTRODUCER 4FR COOK, BECAUSE IT WAS BLOCKED. THE INTRODUCER WAS CHANGED TO 5F AND THE STENT COULD BE INTRODUCED INTO THE PATIENTS ARTERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18535666 ↗MalfunctionDec 5, 2023Premature Activation; Premature Activation
A PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE DISTAL SFA. WHEN INTRODUCING THE DEVICE INTO THE 4F INTRODUCER SHEATH, THE STENT CAME OFF THE SHAFT OUTSIDE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18270556 ↗MalfunctionApr 15, 2020Positioning Failure; Positioning Failure
A PULSAR-18 T3 STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED PRE-DILATED LESION IN A MILDLY TORTUOUS SFA. AFTER THE DEVICE WAS ADVANCED, THE STENT COULD NOT BE RELEASED AND THE DEVICE WAS THEREFORE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9965731 ↗
Other STENT, SUPERFICIAL FEMORAL ARTERY devices
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- 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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