Medline reprocessed electrophysiology catheters recalled for residual material contamination risk
What this means
Specific lots of Medline reprocessed St. Jude Medical Response diagnostic electrophysiology catheters may contain small particles of residual material on surfaces that contact patients. If these particles dislodge during use, they could potentially cause blood clots, inflammation, or infection.
- Check if your facility has catheters from lot EP250203 (item numbers 401206RH or 401305RH).
- Do not use affected catheters.
- Contact Medline Industries for instructions on returning or replacing the devices.
The agency's original wording
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2615-2026More Medline recalls
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