Pulsar-18 T3 6/100/135Recalls & 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 07640130447004), received between Jan 20, 2020 and Jan 20, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (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
- Difficult or Delayed Activation2
- Failure to Advance1
- Fracture1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE MID RENAL ARTERY. AFTER PRE-DILATATION OF THE LESION IN THE RENAL ARTERY THE VESSEL WAS STILL NOT GOOD. THEREFORE, THE PULSAR-18 T3 WAS USED BUT HUGE RESISTANCE DURING DELIVERY WAS EXPERIENCED, THE DEVICE COULD NOT CROSS THE CURVE AND THE SHAFT WAS KINKED DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21194326 ↗MalfunctionNov 30, 2023Fracture; Fracture
THE PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION WITH 100 PERCENT STENOSIS DEGREE IN THE MILDLY TORTUOUS MID SFA. AFTER PRE-DILATATION, THE STENT WAS IMPLANTED IN THE TARGET LESION. INSPECTION ON THE SCREEN SHOWED A FRACTURE IN THE PROXIMAL PART OF THE STENT AFTER INFLATION. ANOTHER PULSAR-18 T3 6/40 STENT WAS IMPLANTED TO COVER THE FRACTURED AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18243201 ↗MalfunctionMay 25, 2023Difficult or Delayed Activation; Difficult or Delayed Activation
A PULSAR-18 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN THE MID PART OF THE MODERATELY TORTUOUS RIGHT SFA. AFTER ADVANCING THE DEVICE TO THE DISEASE SITE AND PRESSING THE RED RELEASE BUTTON, THE WHEEL BECAME HARDER AND HARDER TO TURN DURING DEPLOYMENT. AFTER STRUGGLING TO TURN THE WHEEL, THE STENT FINALLY DEPLOYED BUT WAS THEN STUCK ON THE WIRE. THE SYSTEM/WIRE WAS PULLED OUT AND A NEW WIRE WAS USED TO RECROSS STENT AND BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17004054 ↗MalfunctionJan 20, 2020Difficult or Delayed Activation; Difficult or Delayed Activation
A PULSAR-18 STENT SYSTEM WAS CHOSEN FOR TREATMENT OF THE SFA. DURING DEPLOYMENT ONLY 1/3 OF THE STENT COULD BE RELEASED. FINALLY, A BALLOON WAS USED TO PLACE THE STENT IN THE ARTERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9609194 ↗
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- 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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