Z-2614-2025Class I

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

Name: Z-2614-2025 Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and...
Creator: Medline Industries, LP
Published: 2025-07-31
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-07-31 / Open, Classified

FDA source

Medline Industries, LP began a recall of Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as... on 2025-07-31. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2614-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-07-31
Posted: 2025-09-26
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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
Product code: OWQ Reprocessed Intravascular Ultrasound Catheter
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.
FDA root cause: Under Investigation by firm
Action: On July 31, 2025, the firm notified customers via first class mail and email of the potential product issue. An updated letter was sent to customers on 8/13/25 with additional item and lot numbers. Affected products are to be returned for credit. Customers were instructed to immediately identify and quarantine all affected product within their possession. Once they have completed and returned the response form listing their affected inventory, they will receive return labels and RGA information. Customers will receive credit when the returned product is received.
Quantity in commerce: 7913 eaches
Distribution: Domestic US distribution nationwide. International distribution pending. No international distribution.
Product codes and lots: Item Number/UDI-DI 10135910RH (for use on GE Systems) 10197344026500; 10135936RH (For use on Siemens Systems) 10197344026517; LOTS EP241021 EP241114 EP241226 EP250213 LOTS EP240731 EP240814 EP240826 EP240903 EP240916 EP241003 EP241014 EP241028 EP241104 EP241112 EP241202 EP241209A EP241219 EP241224 EP250114 EP250116 EP250204 EP250219

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2614-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2610-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-09-26
Z-2611-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-09-26
Z-2612-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-09-26
Z-2613-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-09-26
Z-2614-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-09-26

Product code OWQ

K234064Class IIMedline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)Surgical Instrument Service and Savings, Inc. / cleared 2024-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)