Medline recalls reprocessed ViewFlex Xtra ICE catheters with specific lots due to potential residual particulates that could cause infection or blood clots if used in cardiac procedures.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Medline is recalling specific lots of reprocessed ViewFlex Xtra ICE catheters used for heart procedures. These catheters may have small particles that could cause infections or blood clots if used improperly.
The catheters may contain small particles from reprocessing that could cause inflammation or infection. If these particles dislodge during use and enter the bloodstream, they might form blood clots or lead to serious complications like pulmonary embolism.
Healthcare professionals using the reprocessed catheters for cardiac procedures are most at risk. Patients undergoing these procedures with affected catheters could face complications.
Check for the lot numbers listed: EP240731 through EP250219. The catheters are reprocessed ViewFlex Xtra ICE models used for heart procedures.
Identify the lot numbers on the catheter packaging or label to determine if it is in the recalled range.
The recall is due to potential residual particulates in specific lots of reprocessed catheters that could cause infections or blood clots if used in cardiac procedures.
Check the lot numbers on the catheter packaging to see if it is in the recalled range. If it is, contact Medline for instructions.
Yes, patients using affected catheters could face infections or blood clots, which may lead to serious complications like pulmonary embolism.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2613-2025 — Medline Medline Hello, I own a Medline that is covered by recall Z-2613-2025 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.
