Recall Z-2615-2026 ยท NLH Catheter, Recording, Electrode, Reprocessed
Medline Industries, LP
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
| Date | Jul 2, 2026 (initiated May 15, 2026) |
| Status | Open, Classified |
| Reason | Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood 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 | This is an expansion of recall RES 98277. On May 15, 2026, firm notified affected consignee via letter titled "URGENT MEDICAL DEVICE RECALL". All affected product has expired. The consignee was instructed to quarantine all affected product and destroy it. |
| Quantity | 3 |
| Distribution | US Nationwide distribution in the state of TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (40 Surgical Instrument Service and Savings, Inc., Sep 14, 2024 |