Pulsar-18 T3Recalls & reported problems across all models
Biotronik AG · 52 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 124
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 52 models of Pulsar-18 T3 by Biotronik AG in the FDA's device registry (GUDID). Together they are named in 124 adverse event reports in the FDA's MAUDE database, received between Jan 8, 2020 and Aug 20, 2026 — classified as 4 injuries, 120 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (32 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Pulsar-18 T3 problems
Device problems
- Activation Failure32
- Fracture29
- Failure to Advance17
- Material Deformation15
- Positioning Failure12
- Premature Activation11
- Difficult or Delayed Activation7
- Difficult to Remove3
Patient problems
- No Clinical Signs, Symptoms or Conditions95
- No Consequences Or Impact To Patient18
- Insufficient Information7
- Foreign Body In Patient3
- Device Embedded In Tissue or Plaque1
- Hematoma1
- Pain1
- Restenosis1
Pulsar-18 T3 models
52 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Pulsar-18 T3 5/150/135STENT, SUPERFICIAL FEMORAL ARTERY8 reports
- Pulsar-18 T3 6/150/135STENT, SUPERFICIAL FEMORAL ARTERY7 reports
- Pulsar-18 T3 5/200/135STENT, SUPERFICIAL FEMORAL ARTERY6 reports
- Pulsar-18 T3 6/40/135STENT, SUPERFICIAL FEMORAL ARTERY6 reports
- Pulsar-18 T3 4/40/135STENT, SUPERFICIAL FEMORAL ARTERY5 reports
- Pulsar-18 T3 6/80/135STENT, SUPERFICIAL FEMORAL ARTERY5 reports
- Pulsar-18 T3 6/40/90STENT, SUPERFICIAL FEMORAL ARTERY4 reports
- Pulsar-18 T3 6/200/90STENT, SUPERFICIAL FEMORAL ARTERY4 reports
- Pulsar-18 T3 5/40/135STENT, SUPERFICIAL FEMORAL ARTERY4 reports
- Pulsar-18 T3 5/170/135STENT, SUPERFICIAL FEMORAL ARTERY4 reports
- Pulsar-18 T3 6/100/135STENT, SUPERFICIAL FEMORAL ARTERY4 reports
- Pulsar-18 T3 6/200/135STENT, SUPERFICIAL FEMORAL ARTERY4 reports
- Pulsar-18 T3 6/60/90STENT, SUPERFICIAL FEMORAL ARTERY3 reports
- Pulsar-18 T3 6/80/90STENT, SUPERFICIAL FEMORAL ARTERY3 reports
- Pulsar-18 T3 5/80/135STENT, SUPERFICIAL FEMORAL ARTERY3 reports
- Pulsar-18 T3 6/170/135STENT, SUPERFICIAL FEMORAL ARTERY3 reports
- Pulsar-18 T3 7/200/135STENT, SUPERFICIAL FEMORAL ARTERY3 reports
- Pulsar-18 T3 5/20/90STENT, SUPERFICIAL FEMORAL ARTERY2 reports
- Pulsar-18 T3 5/60/90STENT, SUPERFICIAL FEMORAL ARTERY2 reports
- Pulsar-18 T3 5/80/90STENT, SUPERFICIAL FEMORAL ARTERY2 reports
- Pulsar-18 T3 5/170/90STENT, SUPERFICIAL FEMORAL ARTERY2 reports
- Pulsar-18 T3 6/120/90STENT, SUPERFICIAL FEMORAL ARTERY2 reports
- Pulsar-18 T3 6/150/90STENT, SUPERFICIAL FEMORAL ARTERY2 reports
- Pulsar-18 T3 6/170/90STENT, SUPERFICIAL FEMORAL ARTERY2 reports
- Pulsar-18 T3 7/80/90STENT, SUPERFICIAL FEMORAL ARTERY2 reports
- Pulsar-18 T3 5/60/135STENT, SUPERFICIAL FEMORAL ARTERY2 reports
- Pulsar-18 T3 6/60/135STENT, SUPERFICIAL FEMORAL ARTERY2 reports
- Pulsar-18 T3 7/30/135STENT, SUPERFICIAL FEMORAL ARTERY2 reports
- Pulsar-18 T3 7/40/135STENT, SUPERFICIAL FEMORAL ARTERY2 reports
- Pulsar-18 T3 7/60/135STENT, SUPERFICIAL FEMORAL ARTERY2 reports
- Pulsar-18 T3 4/20/90STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 4/40/90STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 4/60/90STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 4/100/90STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 5/40/90STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 5/100/90STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 5/150/90STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 6/20/90STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 6/30/90STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 6/100/90STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 7/60/90STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 4/30/135STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 4/80/135STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 4/100/135STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 4/120/135STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 5/100/135STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 6/20/135STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 6/30/135STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 6/120/135STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 7/100/135STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 7/120/135STENT, SUPERFICIAL FEMORAL ARTERY1 report
- Pulsar-18 T3 7/150/135STENT, SUPERFICIAL FEMORAL ARTERY1 report
Recent Pulsar-18 T3 adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionAug 20, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50339853 ↗MalfunctionJun 5, 2026Labelling, Instructions for Use or Training Problem
A PULSAR-18 T3 SELF-EXPANDABLE PERIPHERAL STENT SYSTEM WAS SELECTED FOR TREATMENT. THE OUTER PACKAGE OF THE PULSAR-18 T3 WAS OPENED DIRECTLY IN THE STERILE AREA, SO THAT THE NON- STERILE PART WAS HANDLED IN THE STERILE FIELD. FINALLY, THE DEVICE WAS OPENED AND SUCCESSFULLY DEPLOYED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25405081 ↗MalfunctionJun 5, 2026Use of Device Problem
THE PULSAR-18 T3 SELF-EXPANDABLE PERIPHERAL STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT WAS IMPLANTED AFTER EXPIRATION DATE. THE ADVERSE EVENT WAS OBSERVED AFTER THE PATIENT'S DISCHARGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25405080 ↗MalfunctionApr 28, 2026Activation Failure
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (80% STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE MID SFA. AFTER PRE-DILATATION OF THE LESION, THE COMPLAINT DEVICE WAS PLACED IN THE LESION BUT DURING RELEASE, THE PROXIMAL END OF THE STENT FAILED TO RELEASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25015188 ↗MalfunctionApr 28, 2026Activation Failure
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (95% STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE MID FEMORAL ARTERY. AFTER PRE-DILATATION OF THE LESION, STENT IMPLANTATION WAS PERFORMED. FIRST, A PULSAR-18 T3 5/170/135 STENT WAS IMPLANTED VIA THE SUPERFICIAL FEMORAL ARTERY AND SUCCESSFULLY RELEASED. SUBSEQUENTLY, THE COMPLAINT DEVICE WAS PLACED BUT FAILED TO RELEASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25015169 ↗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 ↗MalfunctionApr 17, 2026Failure to Advance
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT BUT COULD NOT CROSS.
Patient problems: Insufficient Information
MAUDE report 24908389 ↗MalfunctionMar 24, 2026Activation Failure
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION IN A MILDLY TORTUOUS PART OF THE DISTAL TIBIOPERONEAL TRUNK. THE STENT WOULD NOT DEPLOY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24680239 ↗MalfunctionMar 23, 2026Material Deformation
A PULSAR-18 T3 STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE RIGHT MID SFA. THE LESION WAS PRE-DILATED. DURING STENT DEPLOYMENT, THE STENT DID NOT REACH ITS INTENDED LENGTH OF 200 MM BUT ONLY APPROXIMATELY 120 MM. A SECOND STENT WAS IMPLANTED WITH AN OVERLAP IN ORDER TO COVER THE ORIGINAL LESION LENGTH OF 200 MM.
Patient problems: Insufficient Information
MAUDE report 24662090 ↗MalfunctionMar 18, 2026Fracture
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70-80% STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE RIGHT PROXIMAL SFA. AFTER PRE-DILATION, THE STENT WAS DEPLOYED INTO PROXIMAL RIGHT SFA. UPON REMOVAL OF THE DELIVERY SYSTEM, THE TIP OF THE SYSTEM BROKE OFF. NO HARM TO THE PATIENT WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625445 ↗MalfunctionFeb 20, 2026Fracture
THE GUIDEWIRE WAS ADVANCED ACROSS THE LESION TO CONFIRM THAT THE VESSEL DIAMETER WAS APPROXIMATELY 5 MM. THE PULSAR-18 T3 STENT SYSTEM WAS THEN ADVANCED TO THE TARGET LESION AND THE STENT WAS DEPLOYED. DURING WITHDRAWAL OF THE DELIVERY SYSTEM, A FRACTURE OF PART OF THE DELIVERY SYSTEM WAS IDENTIFIED. THE FRACTURED COMPONENT WAS SUCCESSFULLY RETRIEVED AND REMOVED FROM THE BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400795 ↗MalfunctionJan 7, 2026Failure to Advance
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (75% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID SFA. THE DEVICE COULD NOT PASS THE LESION. AFTER SEVERAL ATTEMPTS ANOTHER PULSAR-18 T3 WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987109 ↗MalfunctionJan 7, 2026Failure to Advance
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (80% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID SFA. THE DEVICE COULD NOT PASS THE LESION. ANOTHER PULSAR-18 T3 WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987108 ↗MalfunctionJan 7, 2026Failure to Advance
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE PROXIMAL SFA. THE DEVICE COULD NOT PASS THE PRE-DILATED LESION. A CUTTING BALLOON WAS USED FOR ADDITIONAL PREPARATION. THEN ANOTHER PULSAR-18 T3 WAS IMPLANTED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987105 ↗
Other Biotronik AG products
All Biotronik AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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