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.
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 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
- Affected units
- 1,087
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.
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.
See all 14 products in this recall →Related recalls
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