ANGIOGUARD RX/XP Emboli Capture Guidewire System Separation Risk
Cordis has recalled 684 units of ANGIOGUARD RX/XP Emboli Capture Guidewire System due to potential separation of the delivery system and capture sheath during use, which could cause stroke or require unplanned surgical intervention.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source reports no illnesses or injuries, and the hazard is described as potential rather than confirmed. Although this is a Class I medical device recall, the combination of no reported harm and a theoretical hazard results in a score of 3 per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Cordis US Corp has recalled 684 units of the ANGIOGUARD RX / XP Emboli Capture Guidewire System, a medical device used in cardiovascular procedures. The affected units have lot numbers 35264208, 35264212, 35265329, 35265654, 35265649, and 35265667 (UDI/DI 20705032054802) and were distributed worldwide.
The device poses a potential for separation of the delivery system and capture sheath during use. This separation may occur during intra-procedural delays or when unplanned percutaneous or surgical intervention is required.
Should separation occur, patients may experience stroke or require unplanned surgical intervention while a replacement device is prepared. Affected healthcare providers should review the lot numbers of devices in inventory and contact Cordis US Corp for guidance regarding alternative options.
The recalled product
- Product
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
- Manufacturer
- Cordis US Corp
- Affected units
- 684
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 (7)
- UDI/DI 20705032054802
- Lot Numbers: 35264208
- 35264212
- 35265329
- 35265654
- 35265649
- 35265667.
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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