FDA Class I Guidewire System Recalled for Device Separation Risk
Cordis US Corp is recalling the ANGIOGUARD RX / XP Emboli Capture Guidewire System because the device may separate during procedures, risking stroke or 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 reflects serious potential hazard. Although no illnesses or injuries have been reported to date, the potential for device separation during critical cardiovascular procedures poses significant risk of stroke or emergency intervention.
Plain-English summary
The FDA has issued a Class I recall of the ANGIOGUARD RX / XP Emboli Capture Guidewire System (Model REF 603014MC), manufactured by Cordis US Corp. The recall addresses a potential hazard in which the delivery system and capture sheath may separate during clinical use.
The separation risk is heightened during situations involving intra-procedural delays, unplanned surgical or percutaneous interventions, or when stroke complications occur. The separation is particularly problematic when it occurs while a replacement device is being prepared, as it may delay or complicate patient care.
Approximately 43 units were distributed worldwide with lot number 35265492. Healthcare providers should contact Cordis US Corp for guidance regarding affected devices and replacement options.
The recalled product
- Product
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
- Manufacturer
- Cordis US Corp
- Affected units
- 43
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 (2)
- UDI/DI 20705032056790
- Lot Numbers: 35265492
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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