Emboli Capture Guidewire System recalls risk of device separation during procedures
Cordis is recalling an emboli capture guidewire system due to potential separation of components during medical procedures. The separation could cause procedural delays, unplanned interventions, or stroke.
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 classification establishes a minimum severity score of 4. The potential for separation of a critical cardiovascular device during procedures could result in stroke or require emergency surgical intervention.
Plain-English summary
The ANGIOGUARD RX / XP Emboli Capture Guidewire System is being recalled by Cordis US Corp due to potential separation of the delivery system and capture sheath. This separation could occur during medical procedures, particularly in situations with intra-procedural delays or when a replacement device is being prepared.
If this separation occurs, patients may experience serious complications including intra-procedural delays, require unplanned percutaneous or surgical intervention, or suffer a stroke. The recall affects 40 units distributed worldwide, identified by Lot Number 35264223 and UDI-DI 20705032054789.
Patients and healthcare providers who may have received this device should take immediate action. If you have received this device, contact your healthcare provider to discuss your individual circumstances and determine whether any measures are necessary to ensure your safety.
The recalled product
- Product
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
- Manufacturer
- Cordis US Corp
- Category
- Medical Device — Cardiovascular
- Hazard
- device-separation
- stroke-risk
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 20705032054789
- Lot Numbers: 35264223
Distribution
Distribution scope not specified by the agency.
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