Recall Z-2426-2018 ยท NLH Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions
Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
| Date | Mar 29, 2018 |
| Status | Terminated |
| Reason | Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic . |
| Root cause | Use error |
| Action | The recalling firm issued a notification letter to their sales representatives via email on 3/29/2018 with a response form. For customers who did not return the response form, their will be a subsequent email or fax to their sales rep. The company will continue to follow up via phone and email as needed. The letter identified the affected product, problem and actions to be taken. |
| Quantity | 2,722 units |
| Distribution | Worldwide Distribution - US Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100254 | REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER Ascent Healthcare Solutions, May 28, 2010 |