LeMaitre Vascular recalls 5F Plus Over the Wire Embolectomy Catheters with specific model numbers due to increased reports of catheters failing to deflate, which may cause tip separation during medical procedures.
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
LeMaitre Vascular is recalling certain models of their 5F Plus Over the Wire Embolectomy Catheters because they have been reported to fail to deflate during use, potentially leading to tip separation. This could cause complications during medical procedures.
The catheter may fail to deflate properly during use, which can cause the tip to separate from the main body. This separation could lead to complications such as blockages or incomplete removal of blood clots during medical procedures.
Healthcare professionals using the LeMaitre 5F Plus Over the Wire Embolectomy Catheter for procedures like embolectomy or thrombectomy are most at risk. Patients undergoing these procedures may also be affected if the catheter fails during treatment.
Check for model numbers 1651-84, e1651-84, 1651-88, e1651-88, or the OTW series numbers listed in the recall notice (e.g., OTW2897, OTW3273). The product is used in medical procedures to remove blood clots.
Identify the model number on the catheter to see if it matches the recalled models listed in the recall notice.
Reach out to LeMaitre Vascular for guidance on whether the catheter needs to be replaced or if there are specific steps to take.
Model numbers 1651-84, e1651-84, 1651-88, e1651-88, and the OTW series numbers listed in the recall notice (e.g., OTW2897, OTW3273) are affected.
There have been increased reports of catheters failing to deflate during use, which may lead to tip separation and potential complications during medical procedures.
The recall does not require immediate discontinuation but advises checking the model number and contacting LeMaitre Vascular for guidance on next steps.
We’ve drafted a message you can send LeMaitre to request your refund or repair — edit it as you like.
Subject: Recall Z-1567-2020 — LeMaitre LeMaitre Hello, I own a LeMaitre that is covered by recall Z-1567-2020 from LeMaitre. 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.
