ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
Reported: May 17, 2023 Initiated: March 24, 2023 #Z-1487-2023
Product Description
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
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.
Details
- Recalling Firm
- Cordis US Corp
- Units Affected
- 146 units
- Distribution
- Worldwide distribution.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC. Recalled by Cordis US Corp. Units affected: 146 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 17, 2023. Severity: Critical. Recall number: Z-1487-2023.
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