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.
Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .
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.
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.
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.
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.
Look for catalog numbers D135303 or D135304 on the catheter packaging or label to confirm if it's affected.
The catheters failed internal testing for non-thrombogenicity, meaning they don't meet the required standard to prevent blood clot formation during cardiac procedures.
Patients who received these catheters during procedures are not directly affected by this recall. Healthcare professionals should check if they have the affected models.
Check the product catalog number on the catheter packaging or label. The recalled models are D135303 and D135304.
We’ve drafted a message you can send Stryker Sustainability Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-2426-2018 — Stryker Sustainability Solutions Stryker Sustainability Solutions Hello, I own a Stryker Sustainability Solutions that is covered by recall Z-2426-2018 from Stryker Sustainability Solutions. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
