[pending] Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electro
Pending LLM rewrite. Source: FDA_DEVICE Z-1321-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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