🔍 RecallPedia

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE

Class I - Dangerous
🏥 Medical Devices Recalled: March 24, 2023 Cordis US Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI/DI 20705032056714; Lot Numbers: 35264218, 35264224, 35264806, 35265342, 35265343, 35265382, 35265383, 35265646, 35265656, 35265658, 35264206, 35265645, 35265653
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cordis US Corp
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1492-2023

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