FDA Device recall Z-1025-2019
Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT Product Usage: The Cook Celect…
- 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 Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT Product Usage: The Cook Celect… by Cook Medical, citing updates to the Instructions for Use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1025-2019 |
| 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 Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-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 | E3401535 E3401362 E3401363 E3401534 E3402132 E3402157 E3402307 E3402707 E3402841 E3402683 E3405426 E3405428…E3401535 E3401362 E3401363 E3401534 E3402132 E3402157 E3402307 E3402707 E3402841 E3402683 E3405426 E3405428 E3405429 E3405427 E3406082 E3406081 E3406079 E3406080 E3406888 E3406887 E3406889 E3406885 E3406886 E3407455 E3407457 E3407456 E3408055 E3408054 E3408510 E3410532 E3410531 E3410533 E3411081 E3412096 E3412066 E3412281 E3412682 E3412855 E3413101 E3412683 E3413409 E3413248 E3413244 E3413243 E3413929 E3413774 E3413773 E3414416 E3414723 E3415128 E3415814 E3415456 E3415455 E3415887 E3416372 E3416488 E3416553 E3416804 E3416489 E3417308 E3417412 E3417552 E3417649 E3418367 E3417918 E3417941 E3418528 E3418610 E3418998 E3419188 E3419234 E3419494 E3419658 E3420361 E3419963 E3419964 E3420625 E3420643 E3420642 E3420069 E3421453 E3421148 E3421697 E3421575 E3421576 E3422528 E3423022 E3424166 E3424689 E3424165 E3425749 E3425157 E3425917 E3425916 E3426573 E3426576 E3427275 E3427415 E3427579 E3427274 |
|---|
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-1025-2019%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.