Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,
Summary
The FDA issued a Class I for Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewi by Medline Industries, LP. Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory re.
Details
Source
Device Recall
External ID
Z-1321-2026
Action Date
2026-02-18
Status
Ongoing
Category
device
Product 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;
Lot/Code Info: 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
Quantity Affected: 41
Reason for Recall
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
Distribution
Distribution US nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-22
Company
Northfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 200 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1321-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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