FDAJuly 31, 2025device

Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

medline industries lpmedlinemedline industries

UPCs

10197344044023101973440440301019734404404710197344044054

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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