Emboli Capture Guidewire System Separation Hazard Prompts FDA Recall
The ANGIOGUARD RX/XP Emboli Capture Guidewire System may separate from its delivery sheath during medical procedures, potentially causing stroke or requiring emergency surgery. Cordis US Corp is recalling 146 units worldwide.
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: This recall is classified as FDA Class I, the agency's most serious classification category. Although no injuries or deaths have been reported to date, the potential failure mode—separation of the guidewire system during a medical procedure—could result in stroke or require emergency surgical intervention, warranting a Severe (Score 4) rating.
Plain-English summary
The ANGIOGUARD RX/XP Emboli Capture Guidewire System, manufactured by Cordis US Corp, is subject to recall due to a potential separation hazard affecting 146 units worldwide.
The delivery system and capture sheath may separate during medical procedures. This separation could occur during intra-procedural delays, unplanned percutaneous or surgical interventions, or other complications.
Device separation during a procedure could result in stroke or require emergency percutaneous or surgical intervention. The affected units are identified by Lot Numbers 35265335 and 35264202 (UDI/DI 20705032056943).
Healthcare facilities using this device should contact Cordis US Corp immediately to determine if they have affected units and obtain guidance on management of this hazard.
The recalled product
- Product
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
- Manufacturer
- Cordis US Corp
- Category
- Medical Device
- Hazard
- device-separation
- stroke
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 (3)
- UDI/DI 20705032056943
- Lot Numbers: 35265335
- 35264202
Distribution
Distribution scope not specified by the agency.
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