The Recall Desk
Severity pendingFDA (Devices)·Z-2614-2025·Announced 2025-10-08

Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of ca

Pending LLM rewrite. Source: FDA_DEVICE Z-2614-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

The recalled product

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 interventio
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Item Number/UDI-DI 10135910RH (for use on GE Systems) 10197344026500
  • 10135936RH (For use on Siemens Systems) 10197344026517

Distribution

Distributed nationwide across the United States.

Related recalls

Same category