LeMaitre Vascular recalls TufTex Embolectomy Catheters (model 3F/4F, lots XSL0097-0099) due to risk of tip breaking off if ligature slips. Affected users should contact for remedy.
Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.
LeMaitre Vascular is recalling TufTex Embolectomy Catheters (3F and 4F models) because three specific lots were released without proper testing. This could cause the catheter tip to break off and become lost in blood vessels.
The catheter's ligature (a tie) was not properly tested before release. If the ligature slips, it could block the inflation hole, causing the catheter tip to break off and become lodged in blood vessels.
Healthcare professionals using the catheter for vascular procedures are most at risk. Patients receiving the catheter during procedures may be affected if the device malfunctions.
Check for model numbers 3F or 4F on the catheter. The affected lots are XSL0097, XSL0098, and XSL0099. This catheter has a latex balloon and single lumen extrusion.
Look for lot numbers XSL0097, XSL0098, or XSL0099 on the catheter packaging or device.
Reach out to LeMaitre Vascular for instructions on how to return or replace the catheter.
The affected models are 3F and 4F TufTex Embolectomy Catheters.
Lots XSL0097, XSL0098, and XSL0099 are recalled.
Check for model numbers 3F or 4F and lot numbers XSL0097, XSL0098, or XSL0099.
We’ve drafted a message you can send LeMaitre Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0228-2023 — LeMaitre Vascular LeMaitre Vascular Hello, I own a LeMaitre Vascular that is covered by recall Z-0228-2023 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.
