Pulsar-18 T3 6/170/135Recalls & 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 07640130447035), received between Dec 8, 2020 and Jan 7, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
- Fracture1
- Positioning Failure1
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.
MalfunctionJan 7, 2026Failure to Advance
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (75% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID SFA. THE DEVICE COULD NOT PASS THE LESION. AFTER SEVERAL ATTEMPTS ANOTHER PULSAR-18 T3 WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987109 ↗MalfunctionSep 30, 2025Fracture; Fracture
AFTER INSERTION OF THE PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM, THE TIP FRACTURED DURING DELIVERY. THE GUIDEWIRE WAS USED TO REMOVE THE FRACTURED PART AND ANOTHER STENT WAS USED FOR THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23178230 ↗MalfunctionDec 8, 2020Positioning Failure; Positioning Failure
A PULSAR-18 T3 PERIPHERAL STENT SYSTEM WAS CHOSEN FOR TREATMENT. THE STENT WAS PLACED, THE RED RELEASE BUTTON WAS PRESSED, THE WHEEL WAS TURNED BUT NOTHING HAPPENED. APPARENTLY, THERE WAS NO CONNECTION FROM THE WHEEL TO THE SHAFT. THE STENT WAS REMOVED AND A NEW STENT WAS RELEASED WITHOUT ANY PROBLEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10972214 ↗
Other STENT, SUPERFICIAL FEMORAL ARTERY devices
- EverFlex™ EVD35-06-150-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 death110 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page