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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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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Spectrum Medical Quantum Perfusion Blood Pump Recalled for Fluid Leakage

Agency Publication Date: March 13, 2025
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Summary

Spectrum Medical Inc is recalling 1,487 units of the Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (Model CP22V-VT). The recall was initiated due to a defect that can cause fluid to leak from the pump during the priming procedure or during clinical medical procedures. No injuries have been reported to date, but the manufacturer is voluntarily taking action to address the potential for leakage.

Risk

Fluid leakage from a blood pump during a medical procedure can disrupt the flow of blood or bypass fluid, potentially causing serious health complications for patients. While no incidents have been reported, the leak creates a risk of device failure during critical surgery.

What You Should Do

  1. This recall affects the Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Model No CP22V-VT. Affected units are identified by UDI-DI 08051160300624 and Lot Numbers F000961, G001207, G001256, and G001511.
  2. Stop using the recalled device immediately.
  3. Contact the manufacturer, Spectrum Medical Inc, or your authorized distributor to arrange for the return, replacement, or correction of the affected equipment.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors
Variants: Non-Roller Type
Model / REF:
CP22V-VT
Lot Numbers:
F000961
G001207
G001256
G001511
UDI:
08051160300624

Pump, Blood, Cardiopulmonary Bypass

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96240
Status: Active
Manufacturer: Spectrum Medical Inc
Sold By: Spectrum Medical Inc
Manufactured In: United States
Units Affected: 1487 unit
Distributed To: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 ยท 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.