ANGIOGUARD RX / XP Emboli Capture Guidewire System separation during procedures
The ANGIOGUARD RX / XP emboli capture guidewire system may separate from its delivery sheath during medical procedures, potentially leading to stroke or complications 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 classification automatically warrants a minimum severity of 4. The potential for device separation during critical cardiovascular procedures, with risk of stroke and other serious complications requiring emergency intervention, justifies a Severe rating.
Plain-English summary
The FDA has issued a Class I recall of the ANGIOGUARD RX / XP Emboli Capture Guidewire System (REF 401814RMC) due to a potential risk of device separation during medical procedures. The delivery system and capture sheath may separate, particularly during intra-procedural delays, requiring unplanned surgical or percutaneous interventions.
This recall affects 283 units with lot numbers 35262517, 35263334, 35264204, 35264222, and 35265345 distributed worldwide. The product is manufactured by Cordis US Corp.
Healthcare providers and facilities using affected units should immediately quarantine them and request replacement devices from Cordis US Corp. Patients treated with this device should consult their healthcare provider if they experience symptoms such as sudden weakness, difficulty speaking, or other signs of stroke or other complications.
The recalled product
- Product
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
- Manufacturer
- Cordis US Corp
- Hazard
- Affected units
- 283
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 (6)
- UDI/DI 20705032053508
- Lot Numbers: 35262517
- 35263334
- 35264204
- 35264222
- 35265345.
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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