Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization Recalled by Medline Industries, LP Due to Specific lots of reprocessed electrophysiology and ultrasound catheters...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medline Industries, LP directly.
Affected Products
Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. Medline Item Numbers 10135910RH 10135936RH
Quantity: 7913 eaches
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medline Industries, LP
Medline Industries, LP has 182 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report