Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach
Medical device recall Z-0875-2022. Published in FDA’s Enforcement Report on Apr 13, 2022.
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 Apr 13, 2022. 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
- 24,641 units 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?
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
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/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918
24,641 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All Lots manufactured within 24 Jan 2019 through 24 Jan 2022. Expiration Dates from January 8, 2022 through January 18 2025. RPN GPN LOT UDI IGTCFS-65-1-UNI-TULIP G52918 E3814493 1082700252918920220114E3814493 IGTCFS-65-1-UNI-TULIP G52918…
Every code shown here, 1,973 characters
All Lots manufactured within 24 Jan 2019 through 24 Jan 2022. Expiration Dates from January 8, 2022 through January 18 2025. RPN GPN LOT UDI IGTCFS-65-1-UNI-TULIP G52918 E3814493 1082700252918920220114E3814493 IGTCFS-65-1-UNI-TULIP G52918 E3817291 1082700252918920220123E3817291 IGTCFS-65-1-UNI-TULIP G52918 E3817898 1082700252918920220125E3817898 IGTCFS-65-1-UNI-TULIP G52918 E3818494 1082700252918920220128E3818494 IGTCFS-65-1-FEM-TULIP G52917 E3813763 1082700252917220220110E3813763 IGTCFS-65-1-FEM-TULIP G52917 E3815476 1082700252917220220116E3815476 IGTCFS-65-1-FEM-TULIP G52917 E3815477 1082700252917220220116E3815477 IGTCFS-65-1-FEM-TULIP G52917 E3817125 1082700252917220220123E3817125 IGTCFS-65-1-FEM-TULIP G52917 E3817562 1082700252917220220124E3817562 IGTCFS-65-1-FEM-TULIP G52917 E3818360 1082700252917220220128E3818360 IGTCFS-65-1-FEM-TULIP G52917 E3818361 1082700252917220220128E3818361 IGTCFS-65-1-FEM-TULIP G52917 E3819474 1082700252917220220131E3819474 IGTCFS-65-1-JUG-TULIP G52916 E3814878 1082700252916520220115E3814878 IGTCFS-65-1-JUG-TULIP G52916 E3815833 1082700252916520220122E3815833 IGTCFS-65-1-JUG-TULIP G52916 E3815866 1082700252916520220122E3815866 IGTCFS-65-1-JUG-TULIP G52916 E3817486 1082700252916520220124E3817486 IGTCFS-65-1-JUG-TULIP G52916 E3817561 1082700252916520220124E3817561 IGTCFS-65-1-JUG-TULIP G52916 E3818790 1082700252916520220129E3818790 IGTCFS-65-1-UNI-TULIP G52918 E3820413 1082700252918920220205E3820413 IGTCFS-65-1-UNI-TULIP G52918 E3821142 1082700252918920220207E3821142 IGTCFS-65-1-UNI-TULIP G52918 E3821784 1082700252918920220211E3821784 IGTCFS-65-1-UNI-TULIP G52918 E3822904 1082700252918920220214E3822904 IGTCFS-65-1-UNI-TULIP G52918 E3825281 1082700252918920220226E3825281 IGTCFS-65-1-UNI-TULIP G52918 E3826948 1082700252918920220228E3826948 IGTCFS-65-1-FEM-TULIP G52917 E3820061 1082700252917220220204E3820061 IGTCFS-65-1-FEM-TULIP G52917 E3820252 1082700252917220220204E3820252 IGTCFS-65-1-FEM-TULIP G52917 E3821156…
FDA’s list runs to 85,772 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.
US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam
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.
The words say it went outside the United States too.
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 14, 2022.
- FDA classified it on Apr 6, 2022.
- FDA’s Enforcement Report published it on Apr 13, 2022.
- FDA terminated it on Nov 7, 2024.
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 85,772 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.