Recall Z-1363-2022— Cordis US Corp

Name: FDA recall Z-1363-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-20

Class II · Ongoing

Class II FDA medical device recall by Cordis US Corp, initiated 2022-05-20. It names one FDA 510(k) clearance: K033394. Product: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.. Reason: Potential for stent dislodgement and associated failures related to two specific sizes of the device..

Recalling firm: Cordis US Corp
Classification: Class II
Status: Ongoing
Initiated: 2022-05-20
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K033394 — CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEMCordis Corp.·cleared 2003-12-22

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

PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.

Reason for recall

Potential for stent dislodgement and associated failures related to two specific sizes of the device.

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