FDA Device recall Z-1024-2019
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT Product Usage: The Cook Celec…
- FDA Device
- Class III
- terminated
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class III recall of Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT Product Usage: The Cook Celec… by Cook Medical, citing updates to the Instructions for Use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1024-2019 |
| 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
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulant therapy is contraindicated; Failure of anticoagulant therapy in thromboembolic diseases; Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and 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 E3403048 E3403049 E3404192 E3404201 E3404200 E3404202 E3404203 E3404806 E3404807 E3404805 E3405421 E340…Lots E3403048 E3403049 E3404192 E3404201 E3404200 E3404202 E3404203 E3404806 E3404807 E3404805 E3405421 E3405422 E3406129 E3406130 E3406933 E3406932 E3406934 E3406931 E3407462 E3407463 E3408063 E3409201 E3409205 E3409202 E3409203 E3409204 E3409840 E3409845 E3409844 E3409841 E3409843 E3410534 E3410536 E3410535 E3411074 E3411075 E3411073 E3411076 E3411732 E3411731 E3412689 E3412690 E3414708 E3414706 E3414707 E3415275 E3415896 E3415895 E3415897 E3416486 E3416487 E3416485 E3417306 E3417305 E3417304 E3417906 E3417904 E3417905 E3418540 E3418541 E3418539 E3419130 E3419131 E3419132 E3419967 E3419968 E3419969 E3420500 E3420499 E3421069 E3421573 E3421574 E3421550 E3422132 E3422539 E3422540 E3422538 E3423717 E3424171 E3424170 E3425141 E3425142 E3425158 E3425901 E3425903 E3425900 E3426575 E3426577 E3426578 E3427278 E3427276 E3427277 E3428150 E3428151 E3428149 E3428876 E3428879 E3428156 E3428880 E3429 |
|---|
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-1024-2019%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.