LeMaitre Vascular Syntel Silicone Catheter Recall: Guide Tip Detachment Risk
LeMaitre Vascular recalls sterile Syntel Silicone Thrombectomy Catheters due to risk of guide tip detachment during vascular procedures. Affected items have specific model numbers and lot codes.
Use caution until it’s fixed
The guide tip can become damaged and result in the tip detaching.
Contact the company
What happened, in plain English
LeMaitre Vascular is recalling sterile Syntel Silicone Thrombectomy Catheters used in vascular grafts and thrombectomies because the guide tip can become damaged and detach. This could lead to complications during medical procedures if the catheter is used improperly. Read more at govinfonow.com/recall/55360-lemaitre-vascular-syntel-silicone-catheter-recall-guide-tip-detachment-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/55360-lemaitre-vascular-syntel-silicone-catheter-recall-guide-tip-detachment-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1824-2024
Cite this page
“LeMaitre Vascular Syntel Silicone Catheter Recall: Guide Tip Detachment Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55360-lemaitre-vascular-syntel-silicone-catheter-recall-guide-tip-detachment-risk. Based on FDA recall #Z-1824-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1824-2024%22&limit=1).
Why it’s dangerous
The guide tip of the catheter can become damaged during use, causing it to detach. If the tip detaches, it could lead to complications such as blockages or injuries during vascular procedures.
Who’s affected
Healthcare professionals using the catheters for vascular grafts and peripheral venous thrombectomies are most at risk. Patients receiving these procedures may be affected if the catheter is used with a damaged guide tip.
How to tell if you have this one
Check for model numbers A4545, A4548, A4554, A4558, A4568 or lot numbers starting with SST1004 to SST1071. These catheters are sold under the brand name Syntel and are used in medical procedures.
- Brand
LeMaitre Vascular- Product
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies- Category
Medical device
What to do — step by step
Check Product Details
Review the model numbers (A4545, A4548, A4554, A4558, A4568) and lot numbers (SST1004 to SST1071) to confirm if your catheter is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 35 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this catheter safe to use?
The recall states the guide tip can become damaged and detach, so it is not safe to use without checking if it is affected by the recall.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1824-2024 (April 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1824-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.