Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach — Class III medical device recall Z-1021-2019
Terminated recall by Cook Medical Incorporated, reported 2019-03-27, distributed nationwide. Updates to the Instructions for Use.
| Recall number | Z-1021-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Medical Incorporated, Bloomington, IN, United States |
| Recall initiated | 2019-02-25 |
| Classified | 2019-03-19 |
| Reported by FDA | 2019-03-27 |
| Terminated | 2020-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 91,731 total |
| Lot numbers | E3403050, E3403652, E3404204, E3404237, E3404808, E3405423, E3407447, E3408093, E3409213, E3409308, E3409842, E3409941, E3410479, E3410911, E3411040, E3413411, E3415129, E3415478, E3415981, E3416515, E3417411, E3417940, E3417942, E3418529, E3418627, E3419268, E3419270, E3420041, E3420068, E3420533, E3420624, E3421063, E3421174, E3421619, E3422914, E3423026, E3423182, E3423841, E3424453, E3425212 and 460 more |
| Model numbers | IGTCFS-65-1-FEM-TULIP |
Product
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.
Reason for recall
Updates to the Instructions for Use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1021-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.