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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Cordis US Corp: 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.

Agency Publication Date: May 11, 2023
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Affected Products

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM

UDI/DI 20705032056738; Lot Numbers: 35265658, 35264211, 35264225, 35265647

Lot Numbers:
Numbers
Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM

UDI/DI 20705032054796; Lot Numbers: 35265644

Lot Numbers:
Numbers
Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE

UDI/DI 20705032056929; Lot Numbers: 35267611

Lot Numbers:
Numbers
Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC

UDI/DI 20705032054789; Lot Numbers: 35264223

Lot Numbers:
Numbers
Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM

UDI/DI 20705032053492; Lot Numbers: 35265339, 35265670

Lot Numbers:
Numbers
Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE

UDI/DI 20705032054772; Lot Numbers: 35264217, 35264226, 35265330, 35265344, 35265381, 35265641, 35265652, 35265655, 35264205, 35264210, 35264214, 35265340, 35265341, 35265394, 35265643

Lot Numbers:
Numbers
Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE

UDI/DI 20705032056714; Lot Numbers: 35264218, 35264224, 35264806, 35265342, 35265343, 35265382, 35265383, 35265646, 35265656, 35265658, 35264206, 35265645, 35265653

Lot Numbers:
Numbers
Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE

UDI/DI 20705032056820; Lot Numbers: 35264219, 35265391, 35265392, 35265399, 35265668, 35265660

Lot Numbers:
Numbers
Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC

UDI/DI 20705032053508; Lot Numbers: 35262517, 35263334, 35264204, 35264222, 35265345.

Lot Numbers:
Numbers
Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC

UDI/DI 20705032054802; Lot Numbers: 35264208, 35264212, 35265329, 35265654, 35265649, 35265667.

Lot Numbers:
Numbers
Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC

UDI/DI 20705032056745; Lot Numbers: 35263328, 35264207, 35264213, 35264216, 35265393, 35265648, 35265659

Lot Numbers:
Numbers
Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC

UDI/DI 20705032056851; Lot Numbers: 35265661

Lot Numbers:
Numbers
Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC

UDI/DI 20705032056943; Lot Numbers: 35265335, 35264202

Lot Numbers:
Numbers
Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC

UDI/DI 20705032056790; Lot Numbers: 35265492

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91922
Status: Active
Manufacturer: Cordis US Corp
Manufactured In: United States
Units Affected: 12 products (283 units; 684 units; 471 units; 54 units; 146 units; 43 units; 40 units; 56 units; 1087 units; 1058 units; 385 units; 27 units)
Agency Last Updated: May 17, 2023

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.