Cordis US Corp: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE

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: 1058 units Lot/code info: UDI/DI 20705032056714; Lot Numbers: 35264218, 35264224, 35264806, 35265342, 35265343, 35265382, 35265383, 35265646, 35265656, 35265658, 35264206, 35265645, 35265653

UPC codes

20705032056714

Source

Official record: FDA (Device enforcement) ↗

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