Coronary Sinus — Class II medical device recall Z-2426-2018
Terminated recall by Stryker Sustainability Solutions, reported 2018-07-18, distributed nationwide. Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not me
| Recall number | Z-2426-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2018-03-29 |
| Classified | 2018-07-12 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2020-07-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 2,722 units |
| Model numbers | D135303, D135304 |
Product
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.
Reason for recall
Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2426-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.