Device recall: Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917…

Class III FDA enforcement event 89689. Recall start date: 14 Feb 2022. Status in the FDA record: Terminated. Termination date: 7 Nov 2024.

Reason for recall, in the words of FDA

IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Cook Medical Incorporated started this device recall on 14 Feb 2022. The firm address in the FDA record is in Bloomington, IN. FDA put the recall in Class III. FDA event 89689 has 2 product records. The first FDA enforcement report date is 13 Apr 2022. The record gives the status Terminated, with the termination date 7 Nov 2024.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam

Recalling firm

Cook Medical Incorporated, Bloomington, IN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 89689: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0875-2022	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	Class III	Terminated	13 Apr 2022
Z-0876-2022	Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;	52,590 units	Class III	Terminated	13 Apr 2022

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Device events that started in 2022: 839
Share of these events in Class III: 4%
Product records in this event: 2Median of the firm: 2
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of Cook Medical Incorporated
Initiated	Product (first record)	Type	Class	Records
18 Sep 2025	Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZT	Device	Class I	1
1 Apr 2024	EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012	Device	Class II	2
25 Feb 2019	Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The G	Device	Class III	6
25 Sep 2018	Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The Zilver 518 and 635 Biliary Stent	Device	Class II	39
22 Mar 2017	Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular	Device	Class I	1
22 Dec 2015	Zilver 518RX Vascular Stent with Rapid Exchange Delivery System	Device	Class II	1
26 Sep 2014	Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that con	Device	Class II	1

Cook Medical Incorporated: all 8 events

Official channels

FDA enforcement report Z-0875-2022The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 89689. https://recallregister.com/fda/iii/89689/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam
What quantity of product is in FDA event 89689?: The event has 2 product records. The first record gives this quantity: 24,641 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2022 have the same class?: 4% of the 839 device events that started in 2022 are in Class III.