Pulsar-18 T3 6/60/90Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130446588), received between Dec 8, 2020 and Dec 19, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (1 report).
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 Failure1
- Failure to Advance1
- Fracture1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2024Failure to Advance; Failure to Advance
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION WITH 10 PERCENT STENOSIS DEGREE IN THE SFA. AFTER PRE-DILATATION, THE DEVICE GOT STUCK INSIDE THE LESION. ANOTHER PULSAR-18 T3 WAS USED AND IMPLANTED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20979102 ↗InjuryMay 14, 2024Fracture; Activation Failure; Fracture; Activation Failure
A PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR A TREATMENT IN THE DISTAL POPLITEAL ARTERY WITH A STENOSIS DEGREE OF 100 PERCENT. DURING TREATMENT APPROXIMATELY 1CM OF THE STENT WAS RELEASED. THE DEPLOYMENT WHEEL KNOB WAS FULLY ROTATED, BUT THE STENT DID NOT OPEN. THE PARTIALLY OPENED STENT WAS PULLED OUT WITH THE INTRODUCER. THE OPENED PART OF THE STENT GOT STUCK AT THE ARTERIAL ENTRY POINT AND THE STENT WAS DISRUPTED. THE SMALL DETACHED PART OF THE STENT WAS REMOVED SURGICALLY.
Patient problems: Insufficient Information
MAUDE report 19315645 ↗MalfunctionDec 8, 2020Positioning Failure; Positioning Failure
A PULSAR-18 T3 PERIPHERAL STENT SYSTEM WAS CHOSEN FOR TREATMENT. THE STENT COULD NOT BE RELEASED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10972234 ↗
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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