Pulsar-18 T3 5/80/135Recalls & 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 07640130446892), received between Feb 26, 2020 and Apr 22, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Failure2
- Lack of Effect1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
- Hematoma1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2025Activation Failure; Activation Failure
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (60 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE MID POPLITEAL ARTERY. THE LESION WAS PRE-DILATED AS REQUIRED, AND THE DEVICE WAS POSITIONED, BUT THE STENT DID NOT EXPAND. FINALLY, WHEN THE SYSTEM WAS REMOVED, THE STENT CAME OUT AS WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21884160 ↗MalfunctionMar 7, 2023Lack of Effect; Lack of Effect
A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID LAD, WHICH OCCURRED DURING STENTING WITH A DES. THE PK PAPYRUS STENT DID NOT SEAL THE PERFORATION PROPERLY. ANOTHER PK PAPYRUS WAS IMPLANTED OVERLAPPING, AND THE PERFORATION WAS SUCCESSFULLY SEALED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16497496 ↗MalfunctionFeb 26, 2020Activation Failure; Activation Failure
A PULSAR-18 T3 STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS POPLITEAL ARTERY. THE SHEATH COULD NOT BE CROSSED WITH THE DEVICE. DURING WITHDRAWAL THE STENT OPENED UP INSIDE AND OUTSIDE PATIENT. THE STENT WAS DELIBERATELY CUT AND 1MM REMAINED IN PATIENT.
Patient problems: Device Embedded In Tissue or Plaque; Hematoma
MAUDE report 9758264 ↗
Other STENT, SUPERFICIAL FEMORAL ARTERY devices
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- 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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