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.
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 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
- Affected units
- 40
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.
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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