Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 4016
FDA device recall Z-2610-2025 · posted 2025-09-26 · Open, Classified
Recall details
- Recalling firm
- Medline Industries, LP
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NLH
- Quantity affected
- 7913 eaches
- Distribution
- Domestic US distribution nationwide. International distribution pending. No international distribution.
- Date initiated
- 2025-07-31
- Date posted
- 2025-09-26
- Location
- Northfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter (K221067) | Surgical Instrument Service and Savings, Inc. | 2023-05-31 |