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.
The guide tip can become damaged and result in the tip detaching.
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.
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.
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.
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.
Review the model numbers (A4545, A4548, A4554, A4558, A4568) and lot numbers (SST1004 to SST1071) to confirm if your catheter is affected.
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.
The recall does not specify a remedy, so contact LeMaitre Vascular directly for guidance on next steps.
Check for model numbers A4545, A4548, A4554, A4558, A4568 or lot numbers starting with SST1004 to SST1071.
We’ve drafted a message you can send LeMaitre Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1824-2024 — LeMaitre Vascular LeMaitre Vascular Hello, I own a LeMaitre Vascular that is covered by recall Z-1824-2024 from LeMaitre Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
