FDA Device recall Z-1026-2019
Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: T…
- 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 and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: T… by Cook Medical, citing updates to the Instructions for Use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1026-2019 |
| 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 and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-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 E3399953 E3401784 E3401785 E3401913 E3401911 E3401914 E3401912 E3402467 E3402464 E3402465 E3402466 E340…Lots E3399953 E3401784 E3401785 E3401913 E3401911 E3401914 E3401912 E3402467 E3402464 E3402465 E3402466 E3403044 E3403041 E3403042 E3404603 E3404602 E3404601 E3404600 E3404797 E3404803 E3404796 E3404802 E3404801 E3405420 E3405418 E3405419 E3405417 E3406127 E3406124 E3406126 E3406125 E3407452 E3407451 E3407453 E3407450 E3407454 E3408090 E3408506 E3411083 E3411084 E3412098 E3412189 E3412100 E3412097 E3412686 E3412684 E3412685 E3413252 E3413251 E3413250 E3413797 E3413798 E3413800 E3413799 E3414417 E3414704 E3414705 E3414703 E3415273 E3415271 E3415272 E3415891 E3415892 E3415893 E3416482 E3416484 E3416481 E3417302 E3417303 E3417301 E3417901 E3417903 E3417902 E3418535 E3418537 E3418536 E3419129 E3419128 E3419127 E3419659 E3419971 E3419972 E3419970 E3420497 E3420498 E3420501 E3421068 E3421067 E3421571 E3421549 E3421551 E3423023 E3423021 E3423024 E3423730 E3423731 E3424173 E3424172 E3425149 E3425 |
|---|
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-1026-2019%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.