Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach
Medical device recall Z-1022-2019. 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?
Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: (1) Pulmonary thromboembolism when anticoagulant therapy is contraindicated; (2) Failure of anticoagulant therapy in thromboembolic diseases; (3) Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and (4) 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 E3401429 E3401430 E3402143 E3402588 E3405430 E3406123 E3406563 E3406890 E3406882 E3407458 E3409899 E3411082 E3411812 E3412279 E3412067 E3412856 E3413249 E3413830 E3413930 E3414511 E3414455 E3414510 E3414724 E3415321 E3415979 E3416514…
Every code shown here, 1,994 characters
Lots E3401429 E3401430 E3402143 E3402588 E3405430 E3406123 E3406563 E3406890 E3406882 E3407458 E3409899 E3411082 E3411812 E3412279 E3412067 E3412856 E3413249 E3413830 E3413930 E3414511 E3414455 E3414510 E3414724 E3415321 E3415979 E3416514 E3417553 E3417943 E3418611 E3419189 E3420042 E3420525 E3420494 E3421070 E3421696 E3422130 E3422590 E3423025 E3423702 E3424222 E3424835 E3425156 E3426022 E3426687 E3426609 E3426686 E3427383 E3427414 E3427856 E3428169 E3428958 E3429392 E3429891 E3430760 E3431331 E3431941 E3432901 E3433348 E3433370 E3433819 E3434227 E3434815 E3435491 E3436594 E3436591 E3436702 E3437087 E3437388 E3438145 E3438963 E3439405 E3439855 E3440465 E3440982 E3440983 E3441422 E3441993 E3442490 E3442479 E3443065 E3443038 E3443528 E3443477 E3443965 E3443926 E3444440 E3444659 E3444658 E3445294 E3445231 E3445822 E3445934 E3446464 E3446727 E3446866 E3447285 E3447887 E3448429 E3449178 E3449541 E3449540 E3450353 E3450352 E3451047 E3451237 E3451758 E3452725 E3452853 E3453330 E3453452 E3453995 E3454604 E3454947 E3455726 E3456374 E3456211 E3456964 E3457716 E3458368 E3460650 E3460610 E3461284 E3461891 E3462517 E3463845 E3465131 E3466739 E3467148 E3468499 E3469569 E3471014 E3471549 E3472125 E3472575 E3476700 E3477042 E3477456 E3477678 E3478734 E3479588 E3480956 E3482537 E3482970 E3483457 E3485412 E3486083 E3487014 E3487369 E3487899 E3488570 E3489154 E3490124 E3490205 E3491269 E3491816 E3493636 E3493547 E3494241 E3494951 E3494797 E3495771 E3495770 E3496651 E3497256 E3497833 E3498718 E3499280 E3499771 E3500582 E3501522 E3501498 E3502270 E3502902 E3503036 E3503589 E3503618 E3504620 E3504619 E3505381 E3506784 E3509615 E3510053 E3510491 E3511152 E3512434 E3513192 E3513554 E3514010 E3514989 E3515626 E3516381 E3516457 E3516458 E3517817 E3518919 E3518918 E3520104 E3520680 E3521302 E3522823 E3523329 E3523874 E3523873 E3524987 E3524936 E3525608 E3526229 E3526632 E3527586 E3528732 E3528791 E3529727 E3530145 E3530142 E3530775 E3531421 E3532048 E3533585 E3533955 E3535227 E3535498…
FDA’s list runs to 5,341 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 5,341 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.