Pulsar-18 T3 6/40/90Recalls & 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
- 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 07640130446571), received between Sep 3, 2020 and Apr 22, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (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
- Activation Failure2
- Fracture2
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2026Failure to Advance; Activation Failure
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (65% STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE SFA. THE DEVICE GOT STUCK IN THE 4F FORTRESS SHEATH AND DID NOT ENTER THE TARGET SFA. WHILE TRYING TO REMOVE THE STENT IT WOULD START DEPLOYING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24949858 ↗MalfunctionAug 22, 2024Activation Failure; Activation Failure
WHILE ADVANCING A PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM THROUGH A 4F SHEATH, IT PARTIALLY DEPLOYED ITSELF WITHIN THE SHEATH, LEAVING A SMALL PORTION OF THE STENT PROTRUDING OUT OF THE END INSERTED IN THE PATIENTS VESSEL. THIS CAUSED THE DEVICE TO BECOME STUCK WITHIN THE SHEATH. BOTH, SHEATH AND DEPLOYMENT DEVICE WERE REMOVED AND EXCHANGED. THIS DID NOT CAUSE ANY TRAUMA TO THE PATIENTS VESSEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20030249 ↗MalfunctionSep 3, 2020Fracture; Fracture
THE PULSAR-18 T3 STENT SYSTEM WAS SELECTED FOR THE TREATMENT. THERE WAS A PROBLEM WITH THE GUIDE WIRE AND IT HAD TO BE REPLACED. THE PULSAR-18 T3 DEVICE HAD ALREADY BEEN PLACED INSIDE THE ARTERY AND HAD TO BE REMOVED AS WELL. DURING REMOVAL, THE STENT GOT STUCK IN THE CORDIS 4F INTRODUCER AND BROKE. A NEW 4F CORDIS INTRODUCER AND A NEW PULSAR-18 T3 (SAME LOT) WERE USED. WHEN INSERTED, THE DEVICE ALSO GOT STUCK IN THE CORDIS 4F INTRODUCER AND BROKE AS WELL (REPORTED SEPARATELY).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10488833 ↗MalfunctionSep 3, 2020Fracture; Fracture
THE PULSAR-18 T3 STENT SYSTEM WAS SELECTED FOR THE TREATMENT. THERE WAS A PROBLEM WITH THE GUIDE WIRE AND IT HAD TO BE REPLACED. THE PULSAR-18 T3 DEVICE HAD ALREADY BEEN PLACED INSIDE THE ARTERY AND HAD TO BE REMOVED AS WELL. DURING REMOVAL, THE STENT GOT STUCK IN THE CORDIS 4F INTRODUCER AND BROKE (REPORTED SEPARATELY). A NEW 4F CORDIS INTRODUCER AND A NEW PULSAR-18 T3 (SAME LOT) WERE USED. WHEN INSERTED, THE DEVICE ALSO GOT STUCK IN THE CORDIS 4F INTRODUCER AND BROKE AS WELL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10488831 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page