ANGIOGUARD Emboli Capture Guidewire System recalled due to potential device separation
Cordis US Corp's ANGIOGUARD RX/XP Emboli Capture Guidewire System is being recalled by the FDA (Class I) because the delivery system and capture sheath may separate during medical procedures, potentially requiring emergency intervention.
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 medical device recall. While no illnesses or deaths are reported in the source, potential device separation during medical procedures could necessitate emergency intervention or result in stroke. FDA's Class I designation reflects the serious potential consequences.
Plain-English summary
Cordis US Corp is recalling the ANGIOGUARD RX/XP Emboli Capture Guidewire System (385 units distributed worldwide). This is an FDA Class I recall.
The ANGIOGUARD RX/XP is an emboli capture guidewire system. There is a potential for the delivery system and capture sheath to separate. This could occur during intra-procedural delays, unplanned percutaneous interventions, or unplanned surgical interventions.
If separation occurs, it could necessitate emergency intervention or result in stroke while awaiting a replacement device. No illnesses or adverse events have been reported to the FDA.
Patients and healthcare facilities using affected product should contact Cordis US Corp. The affected lot numbers are: 35264219, 35265391, 35265392, 35265399, 35265668, 35265660.
The recalled product
- Product
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
- Manufacturer
- Cordis US Corp
- Hazard
- Affected units
- 385
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 20705032056820
- Lot Numbers: 35264219
- 35265391
- 35265392
- 35265399
- 35265668
- 35265660
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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