Recall Z-2610-2025 ยท NLH Catheter, Recording, Electrode, Reprocessed
Medline Industries, LP
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH 401915RH 401918RH 401932RH 401933RH 401934RH 401938RH 401939RH 401940RH 401941RH 401991RH
| 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
| K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter Surgical Instrument Service and Savings, Inc., May 31, 2023 |