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Serious riskFDA DeviceClass I

Medline Livewire catheters recalled for possible residual material

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.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

  1. Check if your facility has received affected lots (model numbers 401582RH, 401940RH, 401904RH, 401914RH, 401932RH, or 401652RH with lot numbers EP250618 or EP250630)
  2. Do not use affected catheters
  3. Contact Medline Industries for instructions on returning or replacing the devices
  4. Notify your institution's medical device coordinator or quality assurance team
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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;
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 7 products — see all of them.

Details

Units affected
41
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class I
Recall number
Z-1321-2026

In the FDA's words

Description
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; 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 401582RH UDI-DI (case) 20888277407517¿ (ea) 10888277407510 Lots EP250618 EP250630; 401940RH UDI-DI 10888277407480 Lot EP250618; 401904RH UDI-DI (case) 20888277407609¿ (ea) 10888277407602 Lots EP250618 EP250630; 401914RH UDI-DI (case) 20888277407524¿ (ea) 10888277407527 Lot EP250618; 401932RH UDI-DI (case) 20888277407678¿ (ea) 10888277407671 Lots EP250618 EP250630; 401652RH UDI-DI 10888277407572 Lots EP250618 EP250630 Distribution: Distribution US nationwide. Affected quantity: 41
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

7 products in this recall

Medline, Abbott and more catheters recalled for embolism risk

Medline is recalling seven groups of reprocessed heart and ultrasound catheters because they may contain small particles of leftover material. If these devices are used, the particles could cause inflammation, infection, or blood clots, which may lead to embolism or deep vein thrombosis. This is an expansion of an earlier recall, and the affected catheters were distributed nationwide.

The agency lists each product separately. Check every one you might have.

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