FDAFDA · Food and drugs·Recall number Z-1490-2023
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
Published May 17, 2023 · Recall initiated: March 24, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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; while a replacement device is prepared.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cordis US Corp
- Distributor
- Worldwide distribution.
- Lot
- UDI/DI 20705032053492; Lot Numbers: 35265339, 35265670
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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