FDA recall Z-1489-2023

Product

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

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.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-03-24

Report date

2023-05-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1489-2023