Syntel Silicone Thrombectomy CatheterRecalls & reported problems across all models
Lemaitre Vascular, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Syntel Silicone Thrombectomy Catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 5 models of Syntel Silicone Thrombectomy Catheter by Lemaitre Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Mar 3, 2023 and Aug 30, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Syntel Silicone Thrombectomy Catheter recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 17, 2024Class IIOpen, Classified
The guide tip can become damaged and result in the tip detaching.
Z-1824-2024 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗
Most reported Syntel Silicone Thrombectomy Catheter problems
Device problems
- Detachment of Device or Device Component3
- Material Separation2
- Device Slipped1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Syntel Silicone Thrombectomy Catheter models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Syntel Silicone Thrombectomy Catheter A4545Catheter, Embolectomy1 recall6 reports
- Syntel Silicone Thrombectomy Catheter A4548Catheter, Embolectomy1 recall0 reports
- Syntel Silicone Thrombectomy Catheter A4554Catheter, Embolectomy1 recall0 reports
- Syntel Silicone Thrombectomy Catheter A4558Catheter, Embolectomy1 recall0 reports
- Syntel Silicone Thrombectomy Catheter A4568Catheter, Embolectomy1 recall0 reports
Recent Syntel Silicone Thrombectomy Catheter adverse event reports
The 6 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 30, 2023Material Separation; Material Separation
IT WAS REPORTED SYNTEL 5F THROMBECTOMY CATHETER HAS A METAL SPRING TIP ON THE END WITH A SILICONE CAP, THIS CAP CAN BE TAKEN OFF WITH FINGERS DURING GRAFT/NATIVE FISTULA DECLOTTING PROCEDURE. WHEN INTERVENTIONIST ENCOUNTERS FRICTION, FROM THE SHEATH OR THE VESSEL WALL, THIS CAP BECOMES LOOSE, AND THE CONCERN IS THAT IT CAN END IN THE PATIENT'S LUNGS. THE SILICONE CAP WAS PLACED BACK ON THE METAL SPRING TIP. NO INJURY OCCURRED TO PATIENT. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORT 1220948-2023-00138 WAS SUBMITTED FOR THE SECOND DEVICE INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17650615 ↗MalfunctionAug 30, 2023Material Separation; Material Separation
IT WAS REPORTED SYNTEL 5F THROMBECTOMY CATHETER HAS A METAL SPRING TIP ON THE END WITH A SILICONE CAP, THIS CAP CAN BE TAKEN OFF WITH FINGERS DURING GRAFT/NATIVE FISTULA DECLOTTING PROCEDURE. WHEN INTERVENTIONIST ENCOUNTERS FRICTION, FROM THE SHEATH OR THE VESSEL WALL, THIS CAP BECOMES LOOSE, AND THE CONCERN IS THAT IT CAN END IN THE PATIENT'S LUNGS. THE SILICONE CAP WAS PLACED BACK ON THE METAL SPRING TIP. NO INJURY OCCURRED TO PATIENT. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORT 1220948-2023-00137 WAS SUBMITTED FOR THE FIRST DEVICE INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17650614 ↗MalfunctionMay 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED AT THE TIME OF PERFORMING A MANEUVER IN THE PROCEDURE, THE GUIDE TIP TENDS TO DETACH IN THE AREA WHERE THE BALLOON IS LOCATED. THERE WERE NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16902474 ↗MalfunctionMay 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THREE TIP OF THE CATHETERS WERE DAMAGED DURING EXTRACTION OF THE THROMBUS. PART OF THE TIP TENDS TO DETACH. THERE WERE NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16862199 ↗MalfunctionMay 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THREE TIP OF THE CATHETERS WERE DAMAGED DURING EXTRACTION OF THE THROMBUS. PART OF THE TIP TENDS TO DETACH. THERE WERE NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16862198 ↗MalfunctionMar 3, 2023Device Slipped; Device Slipped
IT WAS REPORTED THAT THE TIP OF THE SYNTEL SILICONE THROMBECTOMY CATHETER BROKE OFF DURING THE THROMBECTOMY PROCEDURE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16477910 ↗
Other Lemaitre Vascular, Inc. products
- LeMaitre Embolectomy Catheter47 models · 438 reports · 2 recalls
- Pruitt F3 Carotid Shunt10 models · 305 reports
- Artegraft Vascular Graft15 models · 25 reports · 3 recalls
- Trivex System3 models · 69 reports
- Syntel Silicone OTW Embolectomy Catheter8 models · 66 reports
- Pruitt Occlusion Catheter6 models · 5 reports · 1 recall
- Pruitt Irrigation Occlusion Catheter2 models · 4 reports · 1 recall
- LifeSpan ePTFE Vascular Graft10 models · 27 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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