Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach
Medical device recall Z-1021-2019. 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 Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP 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 E3403050 E3403652 E3404237 E3404204 E3404808 E3405423 E3407447 E3408093 E3409308 E3409213 E3409842 E3409941 E3410911 E3410479 E3411040 E3413411 E3415129 E3415478 E3415981 E3416515 E3417411 E3417942 E3417940 E3418627 E3418529 E3419270…
Every code shown here, 1,994 characters
Lots E3403050 E3403652 E3404237 E3404204 E3404808 E3405423 E3407447 E3408093 E3409308 E3409213 E3409842 E3409941 E3410911 E3410479 E3411040 E3413411 E3415129 E3415478 E3415981 E3416515 E3417411 E3417942 E3417940 E3418627 E3418529 E3419270 E3419268 E3420041 E3420068 E3420533 E3420624 E3421063 E3421174 E3421619 E3422914 E3423182 E3423026 E3423841 E3424453 E3425212 E3425232 E3426078 E3430048 E3429969 E3430468 E3430787 E3430786 E3432821 E3433240 E3433849 E3434066 E3434224 E3435003 E3435002 E3434832 E3435832 E3435477 E3436045 E3436046 E3436076 E3436700 E3436593 E3436592 E3437084 E3437525 E3437468 E3438498 E3438066 E3438894 E3438812 E3439458 E3439578 E3440482 E3440392 E3441000 E3441055 E3441400 E3441449 E3442049 E3443066 E3443653 E3443529 E3443969 E3444791 E3445272 E3445813 E3445935 E3446477 E3446772 E3446656 E3447652 E3447282 E3448634 E3448513 E3449620 E3449672 E3450305 E3451275 E3451612 E3451274 E3452079 E3453371 E3453964 E3454174 E3455040 E3455650 E3456227 E3456341 E3456868 E3457301 E3457405 E3457714 E3458446 E3458578 E3458520 E3458580 E3459094 E3459256 E3459191 E3465938 E3466535 E3467143 E3467659 E3468143 E3468494 E3469104 E3470141 E3471018 E3470981 E3471580 E3472127 E3473412 E3473945 E3474510 E3475000 E3475814 E3476805 E3477109 E3477676 E3478512 E3478826 E3479024 E3479429 E3479661 E3480324 E3481781 E3483015 E3483455 E3483884 E3484379 E3485411 E3486067 E3486427 E3487366 E3487882 E3488409 E3488652 E3490204 E3490127 E3491303 E3491876 E3492512 E3492847 E3493553 E3493637 E3494858 E3495766 E3495767 E3496648 E3497135 E3497755 E3498631 E3498754 E3499278 E3499767 E3500580 E3500581 E3501500 E3502176 E3503038 E3502991 E3503590 E3504618 E3504548 E3505382 E3508292 E3508781 E3508780 E3509614 E3510052 E3511119 E3511118 E3512111 E3513195 E3514114 E3514840 E3515665 E3515664 E3516168 E3516456 E3517670 E3517671 E3518917 E3519384 E3520960 E3521666 E3521437 E3522227 E3522553 E3523330 E3523951 E3525607 E3525988 E3526228 E3526227 E3527596 E3527597 E3528089 E3528088 E3528790 E3529726…
FDA’s list runs to 5,503 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 5,503 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.