Pulsar-18 T3 6/200/135Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130447042), received between Jul 16, 2021 and Dec 15, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance2
- Material Deformation2
- Activation Failure1
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2025Failure to Advance; Failure to Advance
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80% STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE PROXIMAL FEMORAL ARTERY. AFTER PRE-DILATATION, THE PULSAR-18 T3 STENT SYSTEM COULD NOT PASS THE LESION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23800884 ↗MalfunctionMar 3, 2025Failure to Advance; Failure to Advance
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (75 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID SFA. DESPITE PRE-DILATATION, THE LESION COULD NOT BE CROSSED WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21510753 ↗MalfunctionDec 11, 2024Malposition of Device; Material Deformation; Activation Failure; Malposition of Device; Material Deformation; Activation Failure
A PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT FOR A SEVERELY CALCIFIED LESION IN THE SFA. AT THE MOMENT OF THE DEPLOYMENT, AFTER HAVING PULLED BACK THE STENT BECAUSE OF MINOR PHYSIOLOGICAL JUMPING OF THE DEVICE WHEN RELEASING THE FIRST STRUTS, THE SHAFT STARTED MOVING DISTALLY, ENDING UP WITH COMPRESSION OF THE STENT AND PROXIMAL MISALIGNMENT/SHORTENING. THIS 6X200MM STENT WAS FINALLY DEPLOYED AT A LENGTH OF ROUGHLY 170MM. AN ADDITIONAL PULSAR 6X60MM WAS DEPLOYED PROXIMALLY TO COVER THE PROXIMAL DISEASED PART LEFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20903454 ↗MalfunctionJul 16, 2021Material Deformation; Material Deformation
A PULSAR-18 T3 6/200/135 PERIPHERAL STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT WAS DEPLOYED IN THE POLITEAL P1 AND SFA. HOWEVER, THE STENT SEEMS TO BE MUCH SHORTER THAN THE ACTUAL LENGTH WHICH IS DESCRIBED ON THE PACKAGING. THUS, A PASSEO-18 (6/200) WAS USED TO MEASURE THE STENT LENGTH AND THE STENT WAS FOUND TO BE ABOUT 40MM SHORTER THAT THE PASSEO-18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12185334 ↗
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- 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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