# FDA recall Z-2614-2025

> **Medline Industries, LP** · Class I · device recall initiated 2025-07-31.

## 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 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.

## Distribution

Domestic US distribution nationwide. International distribution pending. No international distribution.

## Key facts

- **Recall number:** Z-2614-2025
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-31
- **Report date:** 2025-10-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2614-2025

## Citation

> AI Analytics. FDA recall Z-2614-2025. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-2614-2025. Source: US FDA. Licensed CC0.

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