Medline reprocessed St. Jude Supreme diagnostic electrophysiology catheters recalled for residual particles
What this means
Certain lots of reprocessed St. Jude Supreme and Response diagnostic electrophysiology catheters distributed by Medline may contain small particles of leftover material from reprocessing. If used in patients, these particles could cause blood clots, infection, or inflammatory reactions that may lead to serious complications including stroke or blood clots in the lungs or legs.
- Check your facility's inventory against the affected lot numbers (EP250307 and EP250317)
- Stop using any affected catheters immediately
- Contact Medline or your hospital's medical device coordinator for instructions on device removal and patient notification
- Report any patient injuries or complications to the FDA MedWatch program
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-1322-2026More 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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