Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures
Pending LLM rewrite. Source: FDA_DEVICE Z-2611-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
The recalled product
- Product
- Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Item Number/UDI-DI BD710DF282CRH 10197344044023
- BD710DF282RRH 10197344044030
- BD710FJ282CRH 10197344044047
- BD710FJ282RRH 10197344044054
- LOTS EP241216 EP241218 EP241226 EP241231 EP250110 EP250121 EP250210
Distribution
Distributed nationwide across the United States.
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