Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electro
Pending LLM rewrite. Source: FDA_DEVICE Z-1321-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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
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 Cath
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 401940RH UDI-DI 10888277407480 Lot EP250618
- 401914RH UDI-DI (case) 20888277407524¿ (ea) 10888277407527 Lot EP250618
- 401652RH UDI-DI 10888277407572 Lots EP250618 EP250630
Distribution
Distributed nationwide across the United States.
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