FDA Device recall Z-1021-2019
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter…
- FDA Device
- Class III
- terminated
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class III recall of Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter… by Cook Medical, citing updates to the Instructions for Use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1021-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-02-25 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook Medical |
| Distribution | US |
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
Updates to the Instructions for Use.
Identifiers
| code_info | Lots E3403050 E3403652 E3404237 E3404204 E3404808 E3405423 E3407447 E3408093 E3409308 E3409213 E3409842 E340…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 E3451 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1021-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.