Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach
Medical device recall Z-1024-2019. Published in FDA’s Enforcement Report on Mar 27, 2019.
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 Mar 27, 2019. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 91731 total 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 III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Updates to the Instructions for Use.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulant therapy is contraindicated; Failure of anticoagulant therapy in thromboembolic diseases; Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.
91731 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots E3403048 E3403049 E3404192 E3404201 E3404200 E3404202 E3404203 E3404806 E3404807 E3404805 E3405421 E3405422 E3406129 E3406130 E3406933 E3406932 E3406934 E3406931 E3407462 E3407463 E3408063 E3409201 E3409205 E3409202 E3409203 E3409204…
Every code shown here, 1,994 characters
Lots E3403048 E3403049 E3404192 E3404201 E3404200 E3404202 E3404203 E3404806 E3404807 E3404805 E3405421 E3405422 E3406129 E3406130 E3406933 E3406932 E3406934 E3406931 E3407462 E3407463 E3408063 E3409201 E3409205 E3409202 E3409203 E3409204 E3409840 E3409845 E3409844 E3409841 E3409843 E3410534 E3410536 E3410535 E3411074 E3411075 E3411073 E3411076 E3411732 E3411731 E3412689 E3412690 E3414708 E3414706 E3414707 E3415275 E3415896 E3415895 E3415897 E3416486 E3416487 E3416485 E3417306 E3417305 E3417304 E3417906 E3417904 E3417905 E3418540 E3418541 E3418539 E3419130 E3419131 E3419132 E3419967 E3419968 E3419969 E3420500 E3420499 E3421069 E3421573 E3421574 E3421550 E3422132 E3422539 E3422540 E3422538 E3423717 E3424171 E3424170 E3425141 E3425142 E3425158 E3425901 E3425903 E3425900 E3426575 E3426577 E3426578 E3427278 E3427276 E3427277 E3428150 E3428151 E3428149 E3428876 E3428879 E3428156 E3428880 E3429386 E3429384 E3429385 E3429387 E3429887 E3429888 E3429886 E3430768 E3430767 E3431283 E3431871 E3431872 E3432825 E3433331 E3433795 E3433796 E3434810 E3434808 E3434807 E3434809 E3435459 E3435461 E3435462 E3435982 E3435980 E3435979 E3437403 E3437404 E3437402 E3438064 E3438062 E3438063 E3438696 E3438701 E3438700 E3439344 E3439343 E3439858 E3440311 E3440312 E3440310 E3440927 E3440926 E3441399 E3441994 E3441948 E3442464 E3442651 E3443014 E3443611 E3444010 E3444011 E3445369 E3445671 E3445271 E3445810 E3445898 E3446168 E3446488 E3446869 E3446728 E3446775 E3447398 E3447419 E3447879 E3448000 E3448192 E3448512 E3449007 E3448624 E3449177 E3449494 E3449619 E3450304 E3450781 E3450533 E3451609 E3451611 E3451095 E3452077 E3452078 E3452456 E3452673 E3452728 E3453124 E3453454 E3453300 E3453455 E3454197 E3454502 E3454606 E3455433 E3455000 E3455617 E3456680 E3456373 E3456245 E3456682 E3456962 E3457300 E3456963 E3457404 E3457723 E3457777 E3458477 E3459132 E3459691 E3459801 E3459789 E3459654 E3460282 E3460394 E3461242 E3461833 E3462515 E3463400 E3465161 E3465988 E3466737 E3467146 E3467142 E3467642…
FDA’s list runs to 10,687 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.
The products were distributed US Nationwide Distribution
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.
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 Feb 25, 2019.
- FDA classified it on Mar 19, 2019.
- FDA’s Enforcement Report published it on Mar 27, 2019.
- FDA terminated it on Sep 29, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cook Medical Incorporated, of Bloomington, IN.
- 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 10,687 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.