Pulsar-18 T3 6/150/135Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640130447028), received between Apr 8, 2020 and Apr 17, 2026 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 Positioning2
- Fracture2
- Failure to Advance1
- Positioning Failure1
- Self-Activation or Keying1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Failure to Advance
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT BUT COULD NOT CROSS.
Patient problems: Insufficient Information
MAUDE report 24908389 ↗MalfunctionMar 18, 2026Fracture
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70-80% STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE RIGHT PROXIMAL SFA. AFTER PRE-DILATION, THE STENT WAS DEPLOYED INTO PROXIMAL RIGHT SFA. UPON REMOVAL OF THE DELIVERY SYSTEM, THE TIP OF THE SYSTEM BROKE OFF. NO HARM TO THE PATIENT WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625445 ↗InjuryAug 18, 2025Fracture; Fracture
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (75% STENOSIS DEGREE) IN A LOWER EXTREMITY ARTERY. AFTER PRE-DILATATION AND BEFORE STENT PLACEMENT, A METALLIC OBJECT WAS OBSERVED MOVING WITHIN THE VESSEL. AFTER SUCCESSFUL DEPLOYMENT OF THE STENT, THE DELIVERY SYSTEM WAS WITHDRAWN. IT WAS THEN DISCOVERED THAT THE TIP OF THE DELIVERY SYSTEM WAS MISSING. MULTIPLE RETRIEVAL ATTEMPTS WERE MADE TO RECOVER THE DETACHED TIP, BUT THESE WERE UNSUCCESSFUL. THE TIP MIGRATED DISTALLY WITHIN THE LEG VESSEL. DUE TO THE PATIENT'S UNSTABLE CONDITION, SURGICAL REMOVAL VIA VESSEL INCISION WAS CONSIDERED BUT ULTIMATELY NOT PERFORMED. THE PROCEDURE WAS HALTED TO AVOID FURTHER RISK TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22825723 ↗MalfunctionDec 9, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning
A PULSAR-18 T3 STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A 100 PERCENT STENOSIS IN THE SFA. AFTER POSITIONING AND RELEASING ONE THIRD OF THE PULSAR-18 T3 STENT IT WAS VERY DIFFICULT TO RELEASE THE REST OF THE STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10978993 ↗MalfunctionAug 4, 2020Self-Activation or Keying; Self-Activation or Keying
THE PULSAR-18 T3 PERIPHERAL STENT SYSTEM WAS INTRODUCED INTO A CORDIS BRITE TIP 4F INTRODUCER SHEATH SYSTEM AND GOT STUCK INSIDE. UPON THE ATTEMPT TO PULL THE PULSAR-18 T3 OUT OF THE SHEATH THE STENT GOT RELEASED. THUS THE INTRODUCER SHEATH AND THE STENT WERE REMOVED TOGETHER FROM THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10364507 ↗MalfunctionJul 8, 2020Positioning Failure; Positioning Failure
PULSAR-18 T3 STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS SFA. THE STENT COULD NOT BE RELEASED AFTER UNLOCKING THE SAFETY BUTTON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10248463 ↗MalfunctionApr 8, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning
A PULSAR-18 T3 STENT SYSTEM WAS CHOSEN FOR TREATMENT. THE STENT COULD NOT BE RELEASED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9935720 ↗
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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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