Emboli Capture Guidewire System recalled due to potential device separation
Cordis US Corp is recalling the ANGIOGUARD RX/XP Emboli Capture Guidewire System (1,087 units worldwide) due to potential separation of the delivery system and capture sheath, which could lead to 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 designation mandates a minimum severity score of 4. The device presents potential for stroke, a serious injury, if the delivery system and capture sheath separate during use.
Plain-English summary
Cordis US Corp is recalling the ANGIOGUARD RX/XP Emboli Capture Guidewire System (REF 501814RE). The recall affects 1,087 units distributed worldwide under multiple lot numbers.
There is potential for the delivery system and capture sheath to separate during use. This separation could occur during intra-procedural delays, unplanned percutaneous procedures, or unplanned surgical intervention. Such separation poses a risk of stroke and may necessitate additional emergency procedures.
This is an FDA Class I recall, indicating serious potential health risk.
The recalled product
- Product
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE
- 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 (16)
- UDI/DI 20705032054772
- Lot Numbers: 35264217
- 35264226
- 35265330
- 35265344
- 35265381
- 35265641
- 35265652
- 35265655
- 35264205
- 35264210
- 35264214
- 35265340
- 35265341
- 35265394
- 35265643
Distribution
Distribution scope not specified by the agency.
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