Recall Z-2614-2025— Medline Industries, LP

Name: FDA recall Z-2614-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-31

Class I · Ongoing

Class I FDA medical device recall by Medline Industries, LP, initiated 2025-07-31. It names one FDA 510(k) clearance: K234064. Product: 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. Reason: 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..

Recalling firm: Medline Industries, LP
Classification: Class I
Status: Ongoing
Initiated: 2025-07-31
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K234064 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936) +1 moreSurgical Instrument Service and Savings, Inc.·cleared 2024-09-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.