Emboli Capture Guidewire System recalled for component separation risk
The ANGIOGUARD RX/XP Emboli Capture Guidewire System is being recalled because the delivery system and capture sheath may separate during procedures, potentially causing stroke or requiring emergency surgical intervention.
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 medical device recall. Per the severity rubric, Class I recalls never score below 4. While no illnesses or deaths have been reported, the potential for component separation in a critical interventional device, with consequences including stroke or emergency intervention, justifies the Severe classification.
Plain-English summary
The ANGIOGUARD RX/XP Emboli Capture Guidewire System, manufactured by Cordis US Corp, is being recalled by the FDA due to a potential risk of separation between the delivery system and capture sheath during use.
If the components separate during a procedure, consequences may include intra-procedural delay, need for unplanned percutaneous or surgical intervention, or stroke. The affected devices bear UDI/DI 20705032056738 and include lot numbers 35265658, 35264211, 35264225, and 35265647. These devices have been distributed worldwide.
This is a Class I recall. Healthcare providers using affected devices should contact Cordis US Corp for information about replacement devices or further instructions.
The recalled product
- Product
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
- Manufacturer
- Cordis US Corp
- Category
- Medical Device
- Hazard
- component-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 (5)
- UDI/DI 20705032056738
- Lot Numbers: 35265658
- 35264211
- 35264225
- 35265647
Distribution
Distribution scope not specified by the agency.
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