Recall Z-2612-2025 ยท NLH Catheter, Recording, Electrode, Reprocessed
Medline Industries, LP
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
| Date | Sep 26, 2025 (initiated Jul 31, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 7913 eaches |
| Distribution | Domestic US distribution nationwide. International distribution pending. No international distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter Surgical Instrument Service and Savings, Inc., Nov 29, 2024 |