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.
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: 27 units Lot/code info: UDI/DI 20705032056738; Lot Numbers: 35265658, 35264211, 35264225, 35265647
20705032056738
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.