Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
Medical device recall Z-1023-2019. 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 and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther Tulip Filter 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 E3401464 E3401893 E3402589 E3406144 E3406883 E3408507 E3409900 E3412198 E3412763 E3413410 E3413931 E3414482 E3415815 E3415894 E3416490 E3417437 E3417944 E3419495 E3420644 E3423078 E3422549 E3424237 E3425750 E3426734 E3429970 E3433241…
Every code shown here, 1,994 characters
Lots E3401464 E3401893 E3402589 E3406144 E3406883 E3408507 E3409900 E3412198 E3412763 E3413410 E3413931 E3414482 E3415815 E3415894 E3416490 E3417437 E3417944 E3419495 E3420644 E3423078 E3422549 E3424237 E3425750 E3426734 E3429970 E3433241 E3433850 E3434225 E3435234 E3435490 E3436217 E3436703 E3437435 E3438979 E3440364 E3443174 E3443485 E3444721 E3445944 E3447803 E3448635 E3449542 E3450531 E3451318 E3451991 E3452726 E3459706 E3459692 E3472210 E3473370 E3473974 E3473996 E3474508 E3474507 E3474932 E3475433 E3475752 E3476223 E3476716 E3477015 E3477504 E3478220 E3479059 E3482822 E3483889 E3485503 E3486490 E3488010 E3489743 E3490792 E3493642 E3495383 E3497756 E3499264 E3500496 E3501442 E3502173 E3502924 E3503682 E3505357 E3505995 E3506636 E3507648 E3508477 E3509616 E3511197 E3513194 E3513553 E3514576 E3514841 E3517192 E3517195 E3518920 E3522228 E3523668 E3524935 E3526731 E3527598 E3528161 E3529215 E3530605 E3532184 E3532996 E3533849 E3535499 E3535496 E3536288 E3536252 E3537863 E3539744 E3541216 E3542271 E3543848 E3545169 E3545941 E3546339 E3547069 E3547709 E3549157 E3549834 E3550508 E3551262 E3551914 E3553382 E3564483 E3566022 E3566284 E3568007 E3570158 E3570428 E3570429 E3572266 E3572670 E3575220 E3575682 E3575683 E3577284 E3577780 E3578458 E3579047 E3579046 E3579791 E3581075 E3581324 E3582314 E3583886 E3584080 E3585945 E3586421 E3587450 E3588739 E3589667 E3591259 E3593743 E3596339 E3596656 E3599332 E3601137 E3602068 E3603143 E3604737 E3607015 E3607611 E3609975 E3613665 E3615591 E3617730 E3618885 E3619797 E3620043 E3622784 E3623282 E3624216 E3624936 E3625995 E3627401 E3628044 E3629506 E3631055 E3631885 E3632554 E3634199 E3635146 E3635987 E3637817 E3639851 E3642375 E3643756 E3649667 E3650990 E3652539 E3653590 E3655199 E3657169 E3657848 E3662184 E3663755 E3667571 E3668923 E3674332 E3675436 E3676283 E3677418 E3678022 E3678445 E3679638 E3680538 E3681105 E3690817 E3692211 E3692849 E3693347 E3697665 E3698688 E3700759 E3701130 E3702552 E3704509 E3706639 E3707580 E3709390…
FDA’s list runs to 2,587 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 2,587 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.