Webster CS Catheter (Unknown) – particulate risk (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
Lot Codes / Batch Numbers
Item Number/UDI-DI BD710DF282CRH 10197344044023, BD710DF282RRH 10197344044030, BD710FJ282CRH 10197344044047, BD710FJ282RRH 10197344044054, LOTS EP241216 EP241218 EP241226 EP241231 EP250110 EP250121 EP250210
Products Sold
Item Number/UDI-DI BD710DF282CRH 10197344044023; BD710DF282RRH 10197344044030; BD710FJ282CRH 10197344044047; BD710FJ282RRH 10197344044054; LOTS EP241216 EP241218 EP241226 EP241231 EP250110 EP250121 EP250210
A medical device manufacturer is recalling Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures due to Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On July 31, 2025, the firm notified customers via first class mail and email of the potential product issue. An updated letter was sent to customers on 8/13/25 with additional item and lot numbers. Affected products are to be returned for credit. Customers were instructed to immediately identify and quarantine all affected product within their possession. Once they have completed and returned the response form listing their affected inventory, they will receive return labels and RGA information. Customers will receive credit when the returned product is received.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.