FDA Device Recall Z-1490-2023

Cordis US Corp · Miami Lakes, FL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM

Lot / serial / GTIN: UDI/DI 20705032053492; Lot Numbers: 35265339, 35265670

Quantity: 56 units

Reason for recall

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.

Recall record

Recall number: Z-1490-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide distribution.
Recall initiated: 2023-03-24
Classified by FDA Center: 2023-05-11
FDA published: 2023-05-17
Recalling firm: Cordis US Corp
Firm location: Miami Lakes, FL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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