Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach
Medical device recall Z-1026-2019. 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 and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-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 E3399953 E3401784 E3401785 E3401913 E3401911 E3401914 E3401912 E3402467 E3402464 E3402465 E3402466 E3403044 E3403041 E3403042 E3404603 E3404602 E3404601 E3404600 E3404797 E3404803 E3404796 E3404802 E3404801 E3405420 E3405418 E3405419…
Every code shown here, 1,994 characters
Lots E3399953 E3401784 E3401785 E3401913 E3401911 E3401914 E3401912 E3402467 E3402464 E3402465 E3402466 E3403044 E3403041 E3403042 E3404603 E3404602 E3404601 E3404600 E3404797 E3404803 E3404796 E3404802 E3404801 E3405420 E3405418 E3405419 E3405417 E3406127 E3406124 E3406126 E3406125 E3407452 E3407451 E3407453 E3407450 E3407454 E3408090 E3408506 E3411083 E3411084 E3412098 E3412189 E3412100 E3412097 E3412686 E3412684 E3412685 E3413252 E3413251 E3413250 E3413797 E3413798 E3413800 E3413799 E3414417 E3414704 E3414705 E3414703 E3415273 E3415271 E3415272 E3415891 E3415892 E3415893 E3416482 E3416484 E3416481 E3417302 E3417303 E3417301 E3417901 E3417903 E3417902 E3418535 E3418537 E3418536 E3419129 E3419128 E3419127 E3419659 E3419971 E3419972 E3419970 E3420497 E3420498 E3420501 E3421068 E3421067 E3421571 E3421549 E3421551 E3423023 E3423021 E3423024 E3423730 E3423731 E3424173 E3424172 E3425149 E3425150 E3425904 E3425905 E3425906 E3426580 E3426579 E3427281 E3427279 E3427280 E3428157 E3428158 E3428877 E3428881 E3429390 E3429389 E3429893 E3429892 E3429894 E3430769 E3431286 E3431287 E3431881 E3431876 E3433334 E3433333 E3433797 E3434812 E3434811 E3435460 E3435463 E3435981 E3437407 E3437405 E3435978 E3437406 E3438065 E3438697 E3438698 E3439361 E3439363 E3439362 E3439857 E3440314 E3440313 E3440928 E3443357 E3443358 E3444013 E3445026 E3445295 E3445374 E3445816 E3445951 E3446170 E3447020 E3446657 E3447649 E3447909 E3448193 E3448633 E3449008 E3449675 E3449674 E3450108 E3450532 E3450783 E3451610 E3451990 E3452081 E3452080 E3452856 E3453121 E3452727 E3453331 E3453398 E3454503 E3454198 E3454605 E3454999 E3455043 E3455648 E3456681 E3456393 E3456683 E3456340 E3457303 E3456792 E3457302 E3457408 E3457776 E3457846 E3458521 E3459802 E3460283 E3459705 E3460281 E3461892 E3463401 E3464483 E3466030 E3467144 E3467588 E3467674 E3468144 E3469029 E3469570 E3471019 E3471578 E3472208 E3472576 E3472577 E3473999 E3474416 E3475001 E3475422 E3476803 E3477323 E3477322 E3477469 E3477677 E3478134 E3478515…
FDA’s list runs to 8,311 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 8,311 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.