Medline recalls specific reprocessed Livewire catheters due to potential bacterial endotoxin levels. Affected units include model numbers 401582R, 401904R, 401905R, 401933R, and 401991R with certain lot numbers. Contact Medline for details.
Devices may have higher than expected amounts of bacterial endotoxin.
Medline is recalling reprocessed Livewire Steerable Electrophysiology Catheters that may contain higher-than-expected bacterial endotoxin levels. This could pose a risk of infection or other complications during medical procedures. Affected units have specific model numbers and lot numbers listed in the recall notice.
Bacterial endotoxins are components of bacteria that can cause infections when introduced into the body. In medical procedures, these endotoxins could lead to infections or adverse reactions if the catheters are not properly sterilized.
Healthcare professionals using these catheters for electrophysiology procedures are most at risk. Patients receiving these catheters during medical treatments may be affected if the device is used without proper sterilization.
Check for model numbers 401582R, 401904R, 401905R, 401933R, or 401991R with lot numbers EP240528 or EP240805. The catheters were sold with specific UDI-DI numbers listed in the recall notice.
Identify the model number and lot number on the catheter packaging to confirm if it is affected by this recall.
The recall is due to potential higher-than-expected bacterial endotoxin levels in reprocessed Livewire Steerable Electrophysiology Catheters.
Contact Medline directly to confirm if your specific model and lot number are affected and follow their instructions.
Patients using these catheters during medical procedures could face infection risks if the device is not properly sterilized.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1460-2025 — Medline Medline Hello, I own a Medline that is covered by recall Z-1460-2025 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
