FDAMarch 29, 2018device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .
What to do
FDA enforcement status: Terminated
Brands named
stryker sustainability solutionsstrykerstryker sustainability
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- USDA FSISFSIS Issues Public Health Alert for Ravioli Pasta With Beef Sauce Due to Misbranding and Undeclared Allergens2026-05-04
- FDABARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Tip Steerable, Product Number 6DYNTP001;2026-04-10
- FDABARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDADaig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
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