Recall Z-1495-2023— Cordis US Corp

Name: FDA recall Z-1495-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-24

Class I · Ongoing

Class I FDA medical device recall by Cordis US Corp, initiated 2023-03-24. It names one FDA 510(k) clearance: K220654. Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM. Reason: There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared..

Recalling firm: Cordis US Corp
Classification: Class I
Status: Ongoing
Initiated: 2023-03-24
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K220654 — ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis Corporation·cleared 2022-04-06

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

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM

Reason for recall

There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.

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