Pulsar-18 T3 7/40/135Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640130447073), received between Sep 7, 2022 and May 29, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (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
- Activation Failure1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2024Material Deformation; Material Deformation
THE PULSAR-18 T3 SELF-EXPANDABLE STENT WAS DEPLOYED IN THE SFA. THE STENT LOOKED LONGER THAN ADVERTISED LENGTH. MEASUREMENT ON ANGIOGRAPHIC PICTURE SHOWED > 40MM. DEPLOYMENT PROCEEDED AS USUAL WITH NO MOVEMENT OR ELONGATION OF THE STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19415269 ↗MalfunctionSep 7, 2022Activation Failure; Activation Failure
A PULSAR-18 T3 STENT SYSTEM WAS CHOSEN FOR TREATMENT. STENT WAS FLUSHED AS PER USUAL AND WAS ADVANCED OVER AN 0.018 WIRE THROUGH A 4F FORTRESS SHEATH. WHILE ADVANCING THE DEVICE OVER THE WIRE THERE WAS FRICTION, AND IT WAS NOT MOVING FORWARD. AFTER REMOVAL OF THE DEVICE, IT WAS DETECTED THAT A QUARTER OF THE STENT WAS ALREADY DEPLOYED. THE STENT WAS NOT EXPOSED AS IT WAS BEING ADVANCED INTO THE HUB OF THE SHEATH. THE RED LOCK BUTTON WAS NOT DEPRESSED, AND THE DEPLOYMENT WHEEL NOT USED. ANOTHER 7MM STENT WAS USED THROUGH THE SAME SHEATH WITHOUT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15372664 ↗
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- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
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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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