Cordis US Corp: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE

Hazard

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.

Details from the source

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. Quantity: 385 units Lot/code info: UDI/DI 20705032056820; Lot Numbers: 35264219, 35265391, 35265392, 35265399, 35265668, 35265660

UPC codes

20705032056820

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.