Z-2611-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2025
- Initiation Date
- July 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7913 eaches
Product Description
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
Reason for Recall
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.
Distribution Pattern
Domestic US distribution nationwide. International distribution pending. No international distribution.
Code Information
Item Number/UDI-DI BD710DF282CRH 10197344044023; BD710DF282RRH 10197344044030; BD710FJ282CRH 10197344044047; BD710FJ282RRH 10197344044054; LOTS EP241216 EP241218 EP241226 EP241231 EP250110 EP250121 EP250210