ANGIOGUARD RX/XP Emboli Capture Guidewire System May Separate During Procedures
ANGIOGUARD RX/XP emboli capture guidewire systems may separate from their delivery sheaths during interventional procedures, potentially causing stroke. Cordis is recalling 56 units distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall classification requires minimum severity of 4. Device may separate during critical vascular procedures, creating potential for stroke. No reported cases of injury or death at the time of recall, preventing a Critical rating.
Plain-English summary
ANGIOGUARD RX/XP Emboli Capture Guidewire System (Model REF 401814RM) is being recalled by Cordis US Corp. Fifty-six units have been distributed worldwide.
The delivery system and capture sheath of this device may separate during vascular procedures, including situations involving intra-procedural delays, unplanned percutaneous intervention, or unplanned surgical intervention while a replacement device is being prepared. This separation poses a risk of stroke.
Healthcare providers using this device should cease use and contact Cordis US Corp for guidance on device return or replacement. Patients who have undergone procedures with this device should consult their healthcare provider if they experience symptoms of stroke, such as sudden weakness, numbness, difficulty speaking, or facial drooping.
The recalled product
- Product
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
- Manufacturer
- Cordis US Corp
- Hazard
- device-separation
- stroke
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 20705032053492
- Lot Numbers: 35265339
- 35265670
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27