Recall Weekly
Serious riskFDA DeviceClass I

Medline SOUNDSTAR eco catheters recalled for possible particles

Certain lots of reprocessed Biosense Webster SOUNDSTAR eco diagnostic ultrasound catheters may contain small particles of leftover material from manufacturing. If used, these particles could cause blood clots, infection, or other serious complications including stroke or lung embolism.

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

What to do

  1. Check your catheter lot numbers against EP250724 and EP250808
  2. Stop using any affected devices immediately
  3. Contact Medline Industries or your healthcare facility for instructions on replacement or return
  4. If a patient received an affected catheter, contact their healthcare provider right away
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH
Sold in
Nationwide
Made for
Adults

This recall covers 7 products — see all of them.

Details

Units affected
94
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class I
Recall number
Z-1324-2026

In the FDA's words

Description
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH 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 10439072RH UDI-DI 10197344157297 Lots EP250724 EP250808; 10439236RH UDI-DI 10197344157303 Lots EP250724 EP250808; 10438577RH UDI-DI 10197344157273 Lots EP250724 EP250808; 10439011RH UDI-DI (case) 20197344157287¿ (ea) 10197344157280¿ Lots EP250724 EP250808 Distribution: Distribution US nationwide. Affected quantity: 94
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.

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