Recall Z-2611-2025 ยท NLH Catheter, Recording, Electrode, Reprocessed
Medline Industries, LP
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
| 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
| K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocesse Surgical Instrument Service and Savings Inc.(Dba Medline Ren, Nov 15, 2024 |