Medline Biosense Webster SOUNDSTAR eco catheters recalled for residual particles risk
What this means
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.
- Check your catheter lot numbers against EP250724 and EP250808
- Stop using any affected devices immediately
- Contact Medline Industries or your healthcare facility for instructions on replacement or return
- If a patient received an affected catheter, contact their healthcare provider right away
The agency's original wording
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1324-2026More Medline recalls
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- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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