LeMaitre Vascular recalls TufTex Over-the-Wire Embolectomy Catheters with incomplete sterile seals. Affected models include catalog numbers 1651-34 to 1651-88 and E1651-34 to E1651-88. Contact for details.
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
LeMaitre Vascular is recalling TufTex Over-the-Wire Embolectomy Catheters due to incomplete sterile seals in some packages. This could compromise the sterile barrier during medical procedures, potentially leading to infections or contamination.
The sterile barrier in the packaging may not seal properly during manufacturing, which could allow contamination. This risk is specific to medical use and does not pose a hazard to the general public.
Healthcare professionals using the TufTex catheters for medical procedures are most at risk. Patients receiving these catheters during surgery may be affected if the seals are incomplete.
Check for catalog numbers starting with 1651-34 through 1651-88 or E1651-34 through E1651-88. Also look for lot numbers with prefixes OTW, QOT, XOT, or COT that are not expired.
Review the product's catalog number to see if it matches the affected list (1651-34 to 1651-88 or E1651-34 to E1651-88).
Ensure the lot number does not start with OTW, QOT, XOT, or COT and is not expired.
The sterile barrier in the packaging may not seal properly, which could lead to contamination during medical procedures.
Catheters with catalog numbers 1651-34 through 1651-88 or E1651-34 through E1651-88, and lot numbers with prefixes OTW, QOT, XOT, or COT.
No, but healthcare professionals should check the catalog number and lot prefix before use to ensure they are safe.
We’ve drafted a message you can send LeMaitre Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1750-2025 — LeMaitre Vascular LeMaitre Vascular Hello, I own a LeMaitre Vascular that is covered by recall Z-1750-2025 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.
