Pulsar-18 T3 5/170/90Recalls & reported problems
Biotronik AG · Class 3 · Implant
All models of Pulsar-18 T3 (52)
Data updated Oct 16, 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 07640130446533), received between Dec 16, 2020 and Dec 1, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Failure1
- Failure to Deliver1
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.
MalfunctionDec 1, 2025Activation Failure; Activation Failure
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. THE RETRACTABLE SHAFT DID NOT PULL BACK, ALTHOUGH THE DELIVERY WHEEL WAS TURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23679493 ↗MalfunctionDec 16, 2020Failure to Deliver; Failure to Deliver
A PULSAR-18 T3 STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A PRE-DILATED SEVERELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN A SEVERELY TORTUOUS SFA. AFTER PLACING THE DEVICE IN THE TARGET LESION THE RED BUTTON WAS PRESSED BUT THE STENT DID NOT RELEASE FROM SHAFT. WHEN TURNING THE WHEEL, THE RETRACTABLE SHAFT DID NOT MOVE. THE WHOLE DEVICE WAS REMOVED WITH NO DIFFICULTY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WHICH WORKED WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11021543 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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