Pulsar-18 T3 4/100/90Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640130446403), received between Aug 22, 2024 and Aug 22, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2024Fracture; Premature Activation; Fracture; Premature Activation
A PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (STENOSIS DEGREE: 90 PERCENT) IN THE MILDLY TORTUOUS OSTIAL ANTERIOR TIBIAL ARTERY. THE OSTIAL AND MORE DISTAL LESIONS WERE PREDILATED. THEN THE PULSAR-18 T3 WAS ADVANCED DOWN THE WIRE, BUT IT COULD NOT CROSS THE LESION, SINCE IT MET SIGNIFICANT RESISTANCE. THE PULSAR-18 T3 WAS REMOVED WITHOUT UNLOCKING THE HANDLE. ADDITIONAL PRE-DILATATION WAS PERFORMED. DURING REMOVAL OF THE BALLOON DILATATION CATHETER, RESISTANCE AT THE HUB OF THE INTRODUCER SHEATH WAS FELT, AND IT WAS NOTICED THAT THE PULSAR-18 T3 STENT WAS PULLING OUT. THE BALLOON, SHEATH AND THE STENT WERE REMOVED FROM THE PATIENT. ALL THE PARTS OF THE PULSAR-18 T3 CATHETER WERE CHECKED AND WERE INTACT. THE PULSAR-18 T3 DID NOT HAVE ANY PARTS MISSING OR BROKEN EXCEPT THE STENT WAS NOT IN THE UNDEPLOYED CATHETER. BALLOON DILATATION OF THE LESION WAS PERFORMED, AND THE PATIENT WAS DISCHARGED WITHOUT FURTHER INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20024467 ↗
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- 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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