Pulsar-18 T3 7/200/135Recalls & 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
- 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 07640130447141), received between Dec 14, 2023 and Mar 23, 2026 — classified as 3 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
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2026Material Deformation
A PULSAR-18 T3 STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE RIGHT MID SFA. THE LESION WAS PRE-DILATED. DURING STENT DEPLOYMENT, THE STENT DID NOT REACH ITS INTENDED LENGTH OF 200 MM BUT ONLY APPROXIMATELY 120 MM. A SECOND STENT WAS IMPLANTED WITH AN OVERLAP IN ORDER TO COVER THE ORIGINAL LESION LENGTH OF 200 MM.
Patient problems: Insufficient Information
MAUDE report 24662090 ↗MalfunctionFeb 20, 2024Difficult or Delayed Activation; Difficult or Delayed Activation
A PULSAR-18 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. THE RATCHET RELEASE WHEEL STOPPED PRIOR TO RELEASING THE ENTIRE 200MM STENT. THE OPERATOR WAS ABLE TO GET THE STENT OFF THE DELIVERY SYSTEM AND USED A PTA BALLOON AND STENT TO COMPLETE THE CASE. THE STENT REMAINED IN THE VESSEL AS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18737812 ↗MalfunctionDec 14, 2023Difficult or Delayed Activation; Difficult or Delayed Activation
A PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE COULD BE ADVANCED INTO THE CONTRALATERAL FSA. THE RED SAFETY TAB WAS PRESSED AND THE DEPLOYMENT WHEEL TURNED UNTIL IT WAS SUPPOSED TO END. BEFORE REMOVING THE DEVICE, THE DOCTOR NOTICED THAT THE STENT HAD BEEN RELEASED TO 170-180 MM. THE DEPLOYMENT WHEEL WAS THEN PRESSED SEVERAL TIMES. WITH FORCE THE WHEEL COULD THEN BE RELEASED AND TURNED AGAIN, AND THE STENT WAS RELEASED NORMALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18330999 ↗
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- 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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