ViewFlex Xtra ICE Catheter (Unknown) – particulate risk (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Item Number/UDI-DI D087031RH 10197344019557 LOTS EP240731 EP240814 EP240826 EP240903 EP240916 EP241003 EP241014 EP241028 EP241104 EP241112 EP241202 EP241209A EP241219 EP241224 EP250114 EP250116 EP250204 EP250219
A medical device manufacturer is recalling Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices 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.