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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 56
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.
Part of a larger recall action
This product is one of 14 recalled by Cordis US Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
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