Cordis Angioguard Emboli Capture Guidewire System Faces Separation Hazard
Cordis's Angioguard RX/XP Emboli Capture Guidewire System is recalled due to potential separation of the delivery system and capture sheath, which could cause procedural delays, unplanned intervention, or stroke during use.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I recall designation for a medical device with potential for serious procedural complications, including stroke and need for emergency intervention, warrants Critical severity.
Plain-English summary
The FDA has issued a Class I recall for the Cordis Angioguard RX/XP Emboli Capture Guidewire System (product code REF 801814RE; Lot Number 35267611). This medical device is used as a guidewire system with emboli capture capability in vascular intervention procedures.
The recall is due to a potential defect in which the delivery system and capture sheath may separate during use. Separation during a procedure could result in intra-procedural delay while a replacement device is being prepared, or could necessitate unplanned percutaneous or surgical intervention. In potential scenarios, separation could result in stroke.
The affected lot has been distributed worldwide. Patients who have undergone procedures using the affected device should contact their healthcare provider with any questions. Healthcare facilities with remaining stock of Lot 35267611 should discontinue use and contact the manufacturer for replacement devices and additional guidance.
The recalled product
- Product
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
- Manufacturer
- Cordis US Corp
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 20705032056929
- Lot Numbers: 35267611
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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