Recall Z-1241-2022— Cook Incorporated

Name: FDA recall Z-1241-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-05

Class II · Ongoing

Class II FDA medical device recall by Cook Incorporated, initiated 2022-05-05. It names one FDA 510(k) clearance: K153778. Product: Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342 MWCE-18-7-8-NESTER G52739 MWCE-18-7-5-NESTER G23521 MWCE-18-3-3-NESTER G52732 MWCE-18-5-3-NESTER-01 G47334 MWCE-18-7-6-NESTER G52738 MWCE-18-7-6-NESTER-01 G47341 MWCE-18-3-3-NESTER-01 G47332 MWCE-18-7-4-NESTER G52737 MWCE-18-7-3-NESTER G52736 MWCE-18-3-2-NESTER-01 G47331 MWCE-18-5-2-NESTER-01 G47333 MWCE-18-2-2-NESTER-01 G47344 MWCE-18-5-5-NESTER-01 G47335 MWCE-18-7-2-NESTER G52735 MWCE-18-7-4-NESTER-01 G47339 MWCE-18-7-10-NESTER G52741 MWCE-18-5-5-NESTER G23520. Reason: The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula..

Recalling firm: Cook Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2022-05-05
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K153778 — Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated·cleared 2016-05-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342 MWCE-18-7-8-NESTER G52739 MWCE-18-7-5-NESTER G23521 MWCE-18-3-3-NESTER G52732 MWCE-18-5-3-NESTER-01 G47334 MWCE-18-7-6-NESTER G52738 MWCE-18-7-6-NESTER-01 G47341 MWCE-18-3-3-NESTER-01 G47332 MWCE-18-7-4-NESTER G52737 MWCE-18-7-3-NESTER G52736 MWCE-18-3-2-NESTER-01 G47331 MWCE-18-5-2-NESTER-01 G47333 MWCE-18-2-2-NESTER-01 G47344 MWCE-18-5-5-NESTER-01 G47335 MWCE-18-7-2-NESTER G52735 MWCE-18-7-4-NESTER-01 G47339 MWCE-18-7-10-NESTER G52741 MWCE-18-5-5-NESTER G23520

Reason for recall

The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

Data sourced from openFDA. This site is unofficial and independent of the FDA.