Medline Livewire Steerable Electrophysiology Catheters recalled for residual particle contamination
Stop using affected Medline Livewire catheters
Medline Industries is recalling certain lots of reprocessed Livewire Steerable Electrophysiology Catheters because they may contain small particles of residual material left after reprocessing. If used, these particles could cause serious complications including infection, blood clots, or emboli.
- Check if your facility has received affected lots (model numbers 401582RH, 401940RH, 401904RH, 401914RH, 401932RH, or 401652RH with lot numbers EP250618 or EP250630)
- Do not use affected catheters
- Contact Medline Industries for instructions on returning or replacing the devices
- Notify your institution's medical device coordinator or quality assurance team
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1321-2026More Medline Industries, LP recalls
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