Stryker Sustainability Solutions recalls Coronary Sinus Uni-Directional Diagnostic EP
Stryker Sustainability Solutions recalls two specific Coronary Sinus Uni-Directional Diagnostic EP Catheter models (D135303/D135304) due to failing non-thrombogenic specifications in testing. The catheters are used for cardiac electrophysiology mapping.
Lower-risk recall
Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .
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What happened, in plain English
Stryker Sustainability Solutions is recalling two specific models of Coronary Sinus Uni-Directional Diagnostic EP Catheters (D135303 and D135304) because lab tests showed they don't meet the required non-thrombogenic standard. This means they could potentially cause blood clots in normal use during cardiac procedures. Read more at govinfonow.com/recall/71582-stryker-sustainability-solutions-recalls-coronary-sinus-uni-directional-diagnostic-ep.
Source Summary by GovInfoNow · govinfonow.com/recall/71582-stryker-sustainability-solutions-recalls-coronary-sinus-uni-directional-diagnostic-ep · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2426-2018
Cite this page
“Stryker Sustainability Solutions recalls Coronary Sinus Uni-Directional Diagnostic EP.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71582-stryker-sustainability-solutions-recalls-coronary-sinus-uni-directional-diagnostic-ep. Based on FDA recall #Z-2426-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2426-2018%22&limit=1).
Why it’s dangerous
The catheters failed internal testing for non-thrombogenicity, meaning they could potentially cause blood clots during cardiac procedures. However, the hazard is described as a failure to meet specifications rather than a direct risk of injury in normal use.
Who’s affected
Healthcare professionals using these catheters for cardiac electrophysiology procedures are most at risk. Patients who received these catheters during procedures are not directly affected by the recall.
How to tell if you have this one
Check for product catalog numbers D135303 or D135304 on the catheter packaging or label. These are specific models of Coronary Sinus Uni-Directional Diagnostic EP Catheters used for cardiac electrophysiology mapping.
- Brand
Stryker Sustainability Solutions- Category
Medical device
What to do — step by step
Check Product Catalog Number
Look for catalog numbers D135303 or D135304 on the catheter packaging or label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US Nationwide and Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2426-2018 (March 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2426-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.