Z-1492-2023 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 17, 2023
- Initiation Date
- March 24, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1058 units
Product Description
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
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 Pattern
Worldwide distribution.
Code Information
UDI/DI 20705032056714; Lot Numbers: 35264218, 35264224, 35264806, 35265342, 35265343, 35265382, 35265383, 35265646, 35265656, 35265658, 35264206, 35265645, 35265653