Inquiry Steerable Diagnostics Catheter (Unknown) – particulate risk (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 81104RH 81107RH 81174RH 81402RH 81404RH 81405RH 81472RH 81473RH 81474RH 81531RH 81532RH
Lot Codes / Batch Numbers
Item Number/UDI-DI 81102RH 10197344133239, 81104RH 10197344133246, 81107RH 10197344133260, 81174RH 10197344133291, 81402RH 10197344133352, 81404RH 10197344133376, 81405RH 10197344133383, 81472RH 10197344133413, 81473RH 10197344133420, 81474RH 10197344133437, 81531RH 10197344133512, 81532RH 10197344133529, LOTS EP250212 EP250214
Products Sold
Item Number/UDI-DI 81102RH 10197344133239; 81104RH 10197344133246; 81107RH 10197344133260; 81174RH 10197344133291; 81402RH 10197344133352; 81404RH 10197344133376; 81405RH 10197344133383; 81472RH 10197344133413; 81473RH 10197344133420; 81474RH 10197344133437; 81531RH 10197344133512; 81532RH 10197344133529; LOTS EP250212 EP250214
A medical device manufacturer is recalling Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation 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.