FDA Device recall Z-1022-2019
Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP 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 Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP 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-1022-2019 |
| 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 Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP 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 E3401429 E3401430 E3402143 E3402588 E3405430 E3406123 E3406563 E3406890 E3406882 E3407458 E3409899 E341…Lots E3401429 E3401430 E3402143 E3402588 E3405430 E3406123 E3406563 E3406890 E3406882 E3407458 E3409899 E3411082 E3411812 E3412279 E3412067 E3412856 E3413249 E3413830 E3413930 E3414511 E3414455 E3414510 E3414724 E3415321 E3415979 E3416514 E3417553 E3417943 E3418611 E3419189 E3420042 E3420525 E3420494 E3421070 E3421696 E3422130 E3422590 E3423025 E3423702 E3424222 E3424835 E3425156 E3426022 E3426687 E3426609 E3426686 E3427383 E3427414 E3427856 E3428169 E3428958 E3429392 E3429891 E3430760 E3431331 E3431941 E3432901 E3433348 E3433370 E3433819 E3434227 E3434815 E3435491 E3436594 E3436591 E3436702 E3437087 E3437388 E3438145 E3438963 E3439405 E3439855 E3440465 E3440982 E3440983 E3441422 E3441993 E3442490 E3442479 E3443065 E3443038 E3443528 E3443477 E3443965 E3443926 E3444440 E3444659 E3444658 E3445294 E3445231 E3445822 E3445934 E3446464 E3446727 E3446866 E3447285 E3447887 E3448429 E3449178 E3449 |
|---|
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-1022-2019%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.