Pulsar-18 4/150/135Recalls & reported problems
Biotronik AG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640130436466), received between Jul 7, 2021 and Sep 8, 2021 — classified as 1 injury, 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Activation Failure2
- Difficult to Remove1
- Fracture1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2021Fracture; Difficult to Remove; Activation Failure; Fracture; Difficult to Remove; Activation Failure
A PULSAR-18 PERIPHERAL STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (50 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS UNKNOWN VESSEL. THE RELEASE MECHANISM JAMMED AND BROKE. THE STENT WAS PARTIALLY DEPLOYED. IT WAS NOT POSSIBLE TO FULLY DEPLOY OR RETRIEVE THE STENT. FRAGMENT OF THE STENT WAS LEFT IN PUNCTURE SITE.
Patient problems: Failure of Implant
MAUDE report 12438710 ↗MalfunctionJul 7, 2021Activation Failure; Activation Failure
A PULSAR-18 PERIPHERAL STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS MID SFA. THE DEVICE WAS ADVANCED BUT THE STENT DID NOT DEPLOY. THE DEVICE WAS RETRIEVED, THERE WAS NO IMPACT TO THE PATIENT. ANOTHER PULSAR-18 WAS INTRODUCED AND DEPLOYED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12127625 ↗
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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