Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter
Medical device recall Z-2426-2018. Published in FDA’s Enforcement Report on Jul 18, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 18, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2,722 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
2,722 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
2669978 2669987 2688793 2688794 2611427 2683820 2715724 2715729 2715730 2715757 2717434 2717435 2540303 2540308 2669971 2676061 2676062 2676063 2676066 2718603 2718604 2520710 2579520 2597159 2676070 2455042 2698584 2698585 2708150 2708152…
Every code shown here, 2,000 characters
2669978 2669987 2688793 2688794 2611427 2683820 2715724 2715729 2715730 2715757 2717434 2717435 2540303 2540308 2669971 2676061 2676062 2676063 2676066 2718603 2718604 2520710 2579520 2597159 2676070 2455042 2698584 2698585 2708150 2708152 2683539 2728373 2728374 2728471 2728473 2698582 2650600 2671503 2673627 2673753 2676052 2723516 2719375 2728372 2667503 2667504 2667508 2711911 2711913 2714099 2634425 2667502 2463266 2711909 2718456 2718457 2727804 2718454 2718455 2653972 2657505 2660189 2662668 2669911 2669912 2669913 2677027 2677030 2677032 2711065 2711067 2717567 2717568 2717569 2718453 2452247 2563722 2627797 2231657 2650352 2652204 2428771 2431261 2455437 2718392 2487373 2492934 2492935 2492936 2530007 2573328 2575113 2577649 2599284 2632405 2632435 2637254 2641646 2642451 2648809 2455438 2455439 2636330 2645840 2649865 2663765 2663767 2673768 2676056 2676060 2676064 2717822 2711322 2711323 2711324 2711325 2711326 2711096 2711100 2711320 2711059 2711062 2421530 2590901 2629625 2630695 2635829 2728880 2711094 2707509 2707514 2707515 2707516 2444646 2444649 2444650 2594332 2609784 2613319 2613320 2625109 2641491 2641725 2644024 2644025 2708370 2708371 2710839 2728685 2728686 2728688 2728691 2728801 2487850 2629618 2631616 2680821 2713852 2705060 2705297 2705298 2705359 2705364 2690033 2690034 2690035 2690036 2690037 2690038 2699613 2699614 2699697 2700978 2700980 2700981 2642970 2644574 2644575 2670437 2680816 2700987 2700988 2705024 2705041 2705042 2559785 2642964 2684922 2690027 2690028 2690029 2690030 2690031 2570031 2629620 2647031 2654846 2719368 2719384 2728682 2728683 2668243 2668396 2668397 2689336 2689340 2694434 2696789 2696790 2696795 2696999 2697473 2698842 2698843 2702901 2702902 2654855 2692041 2424988 2450374 2457907 2659011 2659019 2684914 2421500 2497497 2498945 2498951 2718694 2503754 2511938 2517832 2533215 2563463 2570030 2668242 2231718 2448728 2461582 2461924 2468439 2473883 2478014 2526468 2553995 2454287 2458190 2552269 2596754 2596758…
FDA’s list runs to 21,775 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Nationwide and Canada
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 29, 2018.
- FDA classified it on Jul 12, 2018.
- FDA’s Enforcement Report published it on Jul 18, 2018.
- FDA terminated it on Jul 28, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Sustainability Solutions, of Tempe, AZ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 21,775 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.