FDA-Device2026-02-18Class IPROCESSING DEFECT

Medline Livewire Steerable Electrophysiology Catheters recalled for residual particle contamination

OTHERNationwide distribution

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
Hazard

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

Sold states
Distribution US nationwide.
Affected count
41
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1321-2026

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