Pulsar-18 T3 6/120/90Recalls & 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 07640130446618), received between Oct 29, 2020 and Mar 16, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture1
- Material Deformation1
- Positioning Failure1
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.
MalfunctionMar 16, 2023Fracture; Fracture
THE PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE MODERATELY TORTUOUS MID SFA. AFTER PRE-DILATATION WAS DONE, A LUMEN WAS SEEN. THE PULSAR-18 T3 WAS ADVANCED OVER A V18 WIRE. RESISTANCE WAS FELT WHEN THE DEVICE WAS INTRODUCED INTO THE 4F SHEATH AND THEREAFTER, THE DEVICE DID NOT WANT TO FOLLOW OVER THE V18 WIRE. IT WAS DECIDED TO PULL BACK THE DEVICE, BUT AT THAT MOMENT THE RETRACTABLE CATHETER ROLLED UP AND THE STENT DEPLOYED. A LOT OF FORCE WAS NEEDED TO PULL BACK THE ENTIRE SYSTEM. IT WAS SEEN THAT THE STENT WAS BROKEN INTO 3 PARTS. THE SHEATH AND DELIVERY SYSTEM WERE TAKEN OUT OF THE PATIENT AS ONE UNIT. THERE WAS STILL ACCESS WITH THE WIRE. DURING THE PLACEMENT OF A 6F SHEATH IT WAS SEEN THAT 2 PARTS OF THE BROKEN STENT WERE AT THE ACCESS SITE AND WERE TAKEN OUT. ONE PART OF THE STENT WAS LEFT AT THE PROXIMAL END OF THE FEMORAL ARTERY. PULSAR-35 STENTS WERE SUCCESSFULLY IMPLANTED AND POST-DILATED, THE SFA WAS RESTORED AND OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16553078 ↗MalfunctionOct 29, 2020Positioning Failure; Material Deformation; Positioning Failure; Material Deformation
THE PULSAR-18 T3 STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. THE STENT COULD NOT BE RELEASED AND AFTER REMOVAL A KINK WAS DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10758855 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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