Medline recalls reprocessed Livewire Steerable Electrophysiology Catheters with specific item numbers and lots due to potential residual particulates that could cause infection or blood clots if used in patients.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Medline is recalling specific reprocessed Livewire Steerable Electrophysiology Catheters that may contain small particles. Using these devices could lead to infections or blood clots in patients, which is why they need to be stopped from use.
The catheters may have small particles left from reprocessing. If these particles get into the patient's blood or heart during use, they could cause infections, blood clots, or serious complications like pulmonary embolism.
Patients undergoing electrophysiology procedures who use the recalled catheters are at risk. Healthcare providers using these specific models should check if their devices are affected.
Check for item numbers 401575RH through 401991RH or lots EP230724 through EP250108 on the catheter packaging or labels. These specific models were reprocessed and sold in the U.S. between 2023 and 2025.
Look for item numbers 401575RH to 401991RH or lots EP230724 to EP250108 on the catheter packaging.
The recall is due to potential small particles left from reprocessing that could cause infections or blood clots if used in patients.
The official notice does not specify a remedy, so you should contact Medline directly for guidance.
Yes, using catheters with residual particles could lead to infections, blood clots, or serious complications like pulmonary embolism.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2610-2025 — Medline Medline Hello, I own a Medline that is covered by recall Z-2610-2025 from Medline. 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.
