Pulsar-18 6/150/135Recalls & reported problems
Biotronik AG · Class 3 · Implant
Data updated Oct 16, 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 07640130436664), received between Jul 7, 2021 and Feb 21, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (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 16, 2026.
Most reported problems
Device problems
- Activation Failure2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2023Activation Failure; Activation Failure
A PULSAR-18 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE PROXIMAL TO MID SFA. WHEN TRYING TO DEPLOY THE STENT, THE CATHETER CONNECTED TO THE TRIGGER, BROKE OFF. THE STENT COULD NOT BE DEPLOYED AND WAS TAKEN OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16413643 ↗MalfunctionMay 12, 2022Fracture; Fracture
A PULSAR-18 PERIPHERAL STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PRE-DILATED SEVERELY CALCIFIED LESION IN THE MID SFA. DURING THE DEPLOYMENT THE TRIGGER QUIT WORKING. THE HANDLE WAS OPENED, AND AN ATTEMPT WAS MADE TO DEPLOY WITH SECONDARY RELEASE, BUT THE STENT BROKE OFF AND A PART OF THE STENT WAS REMOVED. PATIENT WAS FINE AND RECOVERING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14380196 ↗MalfunctionJul 7, 2021Activation Failure; Activation Failure
A PULSAR-18 PERIPHERAL STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (75 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS MID SFA. THE PULSAR 18 STENT WAS DELIVERED TO AFFECTED LESION AREA. AFTER SNAPPING RED SAFETY, CLICKED THE TRIGGER MECHANISM AND THE STENT WOULD NOT DEPLOY. ANOTHER PULSAR-18 WAS USED EFFECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12127101 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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