Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach
Medical device recall Z-1025-2019. 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 Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-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
E3401535 E3401362 E3401363 E3401534 E3402132 E3402157 E3402307 E3402707 E3402841 E3402683 E3405426 E3405428 E3405429 E3405427 E3406082 E3406081 E3406079 E3406080 E3406888 E3406887 E3406889 E3406885 E3406886 E3407455 E3407457 E3407456…
Every code shown here, 1,998 characters
E3401535 E3401362 E3401363 E3401534 E3402132 E3402157 E3402307 E3402707 E3402841 E3402683 E3405426 E3405428 E3405429 E3405427 E3406082 E3406081 E3406079 E3406080 E3406888 E3406887 E3406889 E3406885 E3406886 E3407455 E3407457 E3407456 E3408055 E3408054 E3408510 E3410532 E3410531 E3410533 E3411081 E3412096 E3412066 E3412281 E3412682 E3412855 E3413101 E3412683 E3413409 E3413248 E3413244 E3413243 E3413929 E3413774 E3413773 E3414416 E3414723 E3415128 E3415814 E3415456 E3415455 E3415887 E3416372 E3416488 E3416553 E3416804 E3416489 E3417308 E3417412 E3417552 E3417649 E3418367 E3417918 E3417941 E3418528 E3418610 E3418998 E3419188 E3419234 E3419494 E3419658 E3420361 E3419963 E3419964 E3420625 E3420643 E3420642 E3420069 E3421453 E3421148 E3421697 E3421575 E3421576 E3422528 E3423022 E3424166 E3424689 E3424165 E3425749 E3425157 E3425917 E3425916 E3426573 E3426576 E3427275 E3427415 E3427579 E3427274 E3427855 E3428171 E3428152 E3428888 E3428874 E3428866 E3429388 E3429347 E3429898 E3429890 E3430469 E3430761 E3431285 E3431284 E3431961 E3431873 E3433332 E3434080 E3433820 E3434789 E3434922 E3435416 E3435417 E3435984 E3435983 E3436523 E3436522 E3436945 E3438146 E3439561 E3439345 E3439459 E3439859 E3440317 E3440300 E3440851 E3441382 E3441383 E3441918 E3442978 E3443838 E3443612 E3443927 E3444012 E3445371 E3445232 E3445766 E3446169 E3446476 E3446773 E3447283 E3447421 E3447420 E3448009 E3447805 E3447783 E3448367 E3449182 E3449673 E3450111 E3450782 E3451096 E3451238 E3451992 E3451993 E3452607 E3452675 E3453397 E3453916 E3453994 E3454601 E3454920 E3455041 E3455651 E3455582 E3456246 E3456939 E3457304 E3456793 E3456869 E3457406 E3457715 E3458283 E3457778 E3458895 E3459255 E3461285 E3462516 E3463311 E3465695 E3466500 E3466536 E3467147 E3467643 E3468493 E3468495 E3469011 E3469012 E3469568 E3470982 E3471526 E3471525 E3472128 E3472574 E3473356 E3473413 E3474462 E3474463 E3474933 E3476025 E3475707 E3476466 E3476200 E3477321 E3476946 E3477643 E3477644 E3478514 E3478278 E3478685 E3479343 E3479579…
FDA’s list runs to 8,711 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 8,711 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.