FDA Device recall Z-1198-2019

Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction o…

FDA Device
Class III
terminated
Published 2019-04-24

On 2019-04-24 the FDA classified a Class III recall of Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction o… by Cordis, citing frayed pieces of the mounting card being inside the primary packaging.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1198-2019
Classification	Class III
Status	terminated
Initiated	2019-02-07
Published	2019-04-24
Last updated	2026-09-13 11:55 UTC
Company	Cordis
Distribution	US

Product

Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

Reason

Frayed pieces of the mounting card being inside the primary packaging.

Identifiers

code_info	Lot Number Exp. Date 17744955 12/31/2020 17750783 12/31/2020 17757121 1/31/2021 17735533 10/31/2020 1773… Lot Number Exp. Date 17744955 12/31/2020 17750783 12/31/2020 17757121 1/31/2021 17735533 10/31/2020 17735534 10/31/2020 17744429 12/31/2020 17744430 12/31/2020 17750785 12/31/2020 17757116 1/31/2021 17748743 12/31/2020 17750476 12/31/2020 17755096 1/31/2021 17757122 1/31/2021 17753002 12/31/2020 17779364 4/30/2021 17815946 9/30/2021 17805148 7/31/2021 17815949 9/30/2021 17753959 1/31/2021 17746022 12/31/2020 17762925 2/28/2021 17733016 10/31/2020 17747583 12/31/2020 17749800 12/31/2020 17752698 12/31/2020 17767925 2/28/2021 17769354 3/31/2021 17771053 3/31/2021 17772929 4/30/2021 17722360 9/30/2020 17735189 10/31/2020 17733019 10/31/2020 17746026 12/31/2020 17747584 12/31/2020 17749793 12/31/2020 17752703 12/31/2020 17754875 1/31/2021 17756762 1/31/2021 17762928 2/28/2021 17771058 3/31/2021 17772931 4/30/2021 17816029 9/30/2021 1781763

code_info

Lot Number Exp. Date 17744955 12/31/2020 17750783 12/31/2020 17757121 1/31/2021 17735533 10/31/2020 1773…

Lot Number Exp. Date 17744955 12/31/2020 17750783 12/31/2020 17757121 1/31/2021 17735533 10/31/2020 17735534 10/31/2020 17744429 12/31/2020 17744430 12/31/2020 17750785 12/31/2020 17757116 1/31/2021 17748743 12/31/2020 17750476 12/31/2020 17755096 1/31/2021 17757122 1/31/2021 17753002 12/31/2020 17779364 4/30/2021 17815946 9/30/2021 17805148 7/31/2021 17815949 9/30/2021 17753959 1/31/2021 17746022 12/31/2020 17762925 2/28/2021 17733016 10/31/2020 17747583 12/31/2020 17749800 12/31/2020 17752698 12/31/2020 17767925 2/28/2021 17769354 3/31/2021 17771053 3/31/2021 17772929 4/30/2021 17722360 9/30/2020 17735189 10/31/2020 17733019 10/31/2020 17746026 12/31/2020 17747584 12/31/2020 17749793 12/31/2020 17752703 12/31/2020 17754875 1/31/2021 17756762 1/31/2021 17762928 2/28/2021 17771058 3/31/2021 17772931 4/30/2021 17816029 9/30/2021 1781763

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-1198-2019%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.