FDA Device recall Z-1023-2019
Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther T…
- 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 and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther T… by Cook Medical, citing updates to the Instructions for Use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1023-2019 |
| 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 and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther Tulip Filter 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 E3401464 E3401893 E3402589 E3406144 E3406883 E3408507 E3409900 E3412198 E3412763 E3413410 E3413931 E341…Lots E3401464 E3401893 E3402589 E3406144 E3406883 E3408507 E3409900 E3412198 E3412763 E3413410 E3413931 E3414482 E3415815 E3415894 E3416490 E3417437 E3417944 E3419495 E3420644 E3423078 E3422549 E3424237 E3425750 E3426734 E3429970 E3433241 E3433850 E3434225 E3435234 E3435490 E3436217 E3436703 E3437435 E3438979 E3440364 E3443174 E3443485 E3444721 E3445944 E3447803 E3448635 E3449542 E3450531 E3451318 E3451991 E3452726 E3459706 E3459692 E3472210 E3473370 E3473974 E3473996 E3474508 E3474507 E3474932 E3475433 E3475752 E3476223 E3476716 E3477015 E3477504 E3478220 E3479059 E3482822 E3483889 E3485503 E3486490 E3488010 E3489743 E3490792 E3493642 E3495383 E3497756 E3499264 E3500496 E3501442 E3502173 E3502924 E3503682 E3505357 E3505995 E3506636 E3507648 E3508477 E3509616 E3511197 E3513194 E3513553 E3514576 E3514841 E3517192 E3517195 E3518920 E3522228 E3523668 E3524935 E3526731 E3527598 E3528161 E3529 |
|---|
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-1023-2019%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.