Pulsar-18 T3 6/80/135Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640130446991), received between Aug 18, 2022 and Aug 20, 2026 — classified as 5 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
- Difficult to Remove1
- Failure to Advance1
- Fracture1
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2026Premature Activation; Activation Failure
The Pulsar-18 T3 self-expandable peripheral stent system was selected for treatment of the right SFA. Following pre-dilatation and Shockwave, the device was successfully advanced to the target lesion. An attempt was made to deploy the stent; however, the deployment wheel stopped moving and the stent could not be released. During withdrawal of the device, the stent partially deployed within the introducer sheath. The device was completely removed. There was no harm to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50339854 ↗MalfunctionNov 27, 2024Failure to Advance; Failure to Advance
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE LEFT SFA. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. ANOTHER STENT WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20791256 ↗MalfunctionOct 24, 2024Activation Failure; Activation Failure
PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION WITH 60 PERCENT STENOSIS DEGREE. AFTER PRE-DILATATION, THE DEVICE WAS ADVANCED TO THE LESION BUT THE STENT COULD NOT BE RELEASED. ANOTHER STENT WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20521473 ↗MalfunctionNov 3, 2022Difficult to Remove; Difficult to Remove
A PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE COULD ONLY BE ADVANCED OVER THE WIRE WITH DIFFICULTY. AFTER THE STENT WAS DEPLOYED, THE STENT SYSTEM COULD NOT BE REMOVED AND EVERYTHING HAD TO BE PULL OUT TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15722587 ↗MalfunctionAug 18, 2022Fracture; Fracture
A PULSAR-18 T3 STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS PROXIMAL SFA. AFTER PREDILATATION ONE PULSAR-18 T3 WAS IMPLANTED, ANOTHER DILATATION WITH A PASSEO-18 LUX WAS PERFORMED AND THEN A SECOND PULSAR-18 T3 (COMPLAINT DEVICE) WAS IMPLANTED. DURING WITHDRAWAL RESISTANCE WAS FELT. IT WAS DETECTED THAT CA. 15 CM OF THE SHAFT FRACTURED AND REMAINED ON THE DELIVERY SYSTEM. ALL PARTS COULD BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15250794 ↗
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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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