Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22… recallZ-1327-2025 · Spectrum Medical Inc · initiated Jan 16, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spectrum Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
FDA root cause category: Process control
What the company is doing
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
Recall details
- Recall number
- Z-1327-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 16, 2025
- Posted by the FDA
- Mar 13, 2025
- Recalling firm
- Spectrum Medical Inc
- Quantity
- 1487 unit
- Product code
- KFM
- FDA submissions
- K201320
- Distribution
- 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.
Product description
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
Code information (models, lots, serial numbers)
Lot Code: Model No CP22V-VT; UDI-DI 08051160300624; Lot Numbers F000961, G001207, G001256, G001511
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors CP22V-VTSpectrum Medical Srl · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type1 recall1 death15 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page