ANGIOGUARD RX/XP Emboli Capture Guidewire System Separation Risk
Cordis has recalled 684 units of ANGIOGUARD RX/XP Emboli Capture Guidewire System due to potential separation of the delivery system and capture sheath during use, which could cause stroke or require unplanned surgical 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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke…"
Plain-English summary
Cordis US Corp has recalled 684 units of the ANGIOGUARD RX / XP Emboli Capture Guidewire System, a medical device used in cardiovascular procedures. The affected units have lot numbers 35264208, 35264212, 35265329, 35265654, 35265649, and 35265667 (UDI/DI 20705032054802) and were distributed worldwide.
The device poses a potential for separation of the delivery system and capture sheath during use. This separation may occur during intra-procedural delays or when unplanned percutaneous or surgical intervention is required.
Should separation occur, patients may experience stroke or require unplanned surgical intervention while a replacement device is prepared. Affected healthcare providers should review the lot numbers of devices in inventory and contact Cordis US Corp for guidance regarding alternative options.
The recalled product
- Product
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
- Manufacturer
- Cordis US Corp
- Affected units
- 684
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 20705032054802
- Lot Numbers: 35264208
- 35264212
- 35265329
- 35265654
- 35265649
- 35265667.
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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