ANGIOGUARD RX/XP Guidewire System May Separate During Medical Procedures
The ANGIOGUARD RX/XP Emboli Capture Guidewire System may separate during medical procedures, potentially delaying treatment or requiring unplanned intervention. The recall affects 471 units distributed worldwide.
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: This is an FDA Class I recall. Per the severity rubric, FDA Class I classification requires a minimum score of 4. The potential risk of stroke and procedural complications qualifies as Severe (4) rather than Critical (5), as no actual harm has been reported.
Plain-English summary
The ANGIOGUARD RX/XP Emboli Capture Guidewire System (REF 601814RMC), manufactured by Cordis US Corp, is a medical device used in vascular procedures. The FDA has issued a Class I recall affecting 471 units distributed worldwide.
The recall was issued due to a potential risk of separation between the delivery system and capture sheath. This separation could occur during a procedure, potentially causing procedural delays and requiring unplanned surgical or percutaneous intervention, with potential risk of stroke.
The affected lot numbers are: 35263328, 35264207, 35264213, 35264216, 35265393, 35265648, and 35265659. Healthcare facilities should verify whether they have inventory of the recalled device and contact the manufacturer regarding replacement.
The recalled product
- Product
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
- Manufacturer
- Cordis US Corp
- Hazard
- Affected units
- 471
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 (8)
- UDI/DI 20705032056745
- Lot Numbers: 35263328
- 35264207
- 35264213
- 35264216
- 35265393
- 35265648
- 35265659
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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