Emboli Capture Guidewire System Separation Risk Recalls ANGIOGUARD RX/XP
Cordis US Corp is recalling ANGIOGUARD RX/XP Emboli Capture Guidewire Systems worldwide due to potential separation of the delivery system and capture sheath during procedures, which could cause stroke or require emergency intervention.
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 classification requires a minimum severity of 4. The potential for device separation to cause stroke or require emergency intervention during critical cardiovascular procedures represents serious injury risk.
Plain-English summary
The ANGIOGUARD RX/XP Emboli Capture Guidewire System is a medical device used in cardiovascular procedures to capture blood clots and other debris. Cordis US Corp, the manufacturer, is recalling the device due to a potential separation defect.
The delivery system and capture sheath may separate during a procedure. Such separation could occur during an intra-procedural delay or when unplanned percutaneous or surgical intervention becomes necessary. The potential consequences of separation include patient stroke and complications requiring emergency intervention.
The ANGIOGUARD RX/XP has been distributed worldwide. The recall affects devices bearing Lot Number 35265644, with UDI/DI 20705032054796.
Hospitals and surgical centers using this device should verify the lot number, isolate affected units, and contact Cordis US Corp for replacement device guidance.
The recalled product
- Product
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
- Manufacturer
- Cordis US Corp
- Hazard
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 (2)
- UDI/DI 20705032054796
- Lot Numbers: 35265644
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.
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