🔍 RecallPedia

Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802

Class I - Dangerous
🏥 Medical Devices Recalled: November 13, 2023 Maquet Medical Systems USA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI 04058863074863 and 04037691658384 All serial numbers up to and including 90413927
  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:
Maquet Medical Systems USA
Reason for Recall:
Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be exposed to inappropriate blood flow, blood temperature, or hematocrit/hemoglobin levels as a result of the CARDIOHELP-i not receiving information from the venous probe.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802

Product Codes/Lot Numbers:

UDI-DI 04058863074863 and 04037691658384 All serial numbers up to and including 90413927

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0605-2024

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