Recall Weekly
Serious riskFDA DeviceClass I

Reprocessed Siemens AcuNav catheters recalled for possible particles

Medline Industries is recalling certain lots of reprocessed Siemens ACUSON AcuNav ultrasound catheters because they may contain small particles of leftover material from reprocessing. If used, these particles could cause inflammation, infection, or blood clots that may lead to serious complications including stroke or pulmonary embolism.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

  1. Check if your facility has any of the affected catheter lots: EP250324, EP250429, EP250521, EP250609, EP250630, EP250710, or EP250905
  2. Stop using affected catheters immediately and quarantine them
  3. Contact Medline Industries for replacement or return instructions
  4. Notify your healthcare team and patients who may have received procedures with affected catheters
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 7 products — see all of them.

Details

Units affected
511
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class I
Recall number
Z-1325-2026

In the FDA's words

Description
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 10135910RH UDI-DI 10197344026500 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905; 10135936RH UDI-DI 10197344026517 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905 Distribution: Distribution US nationwide. Affected quantity: 511
Hazard
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

7 products in this recall

Medline, Abbott and more catheters recalled for embolism risk

Medline is recalling seven groups of reprocessed heart and ultrasound catheters because they may contain small particles of leftover material. If these devices are used, the particles could cause inflammation, infection, or blood clots, which may lead to embolism or deep vein thrombosis. This is an expansion of an earlier recall, and the affected catheters were distributed nationwide.

The agency lists each product separately. Check every one you might have.

More from Medline

See all

Related topics

OtherMedical devicesSold nationwideMore from FDA Device