Cordis US Corp: Medical Device Recall in 2023 - (Recall #: Z-1491-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: March 24, 2023

Date Posted: May 17, 2023

Recall Number: Z-1491-2023

Event ID: 91922

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.

Status: Ongoing

Product Quantity: 1087 units

Code Information:

UDI/DI 20705032054772; Lot Numbers: 35264217, 35264226, 35265330, 35265344, 35265381, 35265641, 35265652, 35265655, 35264205, 35264210, 35264214, 35265340, 35265341, 35265394, 35265643

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated