Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A
FDA Recall Z-1327-2025 · Posted 2025-03-13
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Recalling FirmSpectrum Medical Inc
Recall StatusOpen, Classified
Product CodeKFM
Date Initiated2025-01-16
Product Quantity1487 unit
Reason for Recall
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Firm Action
On January 16, 2025, Spectrum Medical issued a Medical Device Recall notification to affected consignees via E-Mail. Spectrum Medical asked consignees to take the following actions:
1. Send back the Spectrum Medical Inc. a copy of the "Medical Device Recall Return Response" attached with all fields completed by emailing ht
Root Cause
Process control
Distribution Pattern
US Nationwide distribution including in the states of 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, and Washington.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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