Blood Pump Recalled for Potential Fluid Leakage During Clinical Use
Spectrum Medical is recalling Quantum Perfusion blood pumps due to potential fluid leakage during priming or clinical use. The issue affects approximately 1,487 units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported injuries or incidents. The recalled blood pump is used in critical cardiac surgery where fluid leakage could pose risk, but this hazard is theoretical with no documented incidents in the source text.
Plain-English summary
Spectrum Medical Inc is recalling the Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (model CP22V-VT). This device is a non-roller type blood pump used during cardiopulmonary bypass procedures to circulate blood during cardiac surgery.
The recall was issued due to the potential for fluid leakage from the pump. This leakage could occur during the device priming procedure or during clinical use. The affected units correspond to specific lot numbers: F000961, G001207, G001256, and G001511.
Approximately 1,487 units have been distributed nationwide to healthcare facilities across the United States. The recalled devices have been distributed to hospitals and surgical centers in 28 states and the District of Columbia.
Healthcare facilities in possession of affected units should contact Spectrum Medical Inc immediately for instructions. The manufacturer has classified this as a Class II recall. No patient action is necessary, as the device is used only by trained medical personnel in surgical settings.
The recalled product
- Product
- 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
- Manufacturer
- Spectrum Medical Inc
- Affected units
- 1,487
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot Code: Model No CP22V-VT
- UDI-DI 08051160300624
- Lot Numbers F000961
- G001207
- G001256
- G001511
Distribution
Related recalls
Same hazard · fluid leakage
See all →- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
- HighHalyard STANDARD LINE INSERTION PACK Recall for Silicone Seal Defect
FDA (Devices) · 2026-07-29
Similar recalls
- SevereSpectrum Medical Recalls Quantum Pump Consoles Due to Shutdown Risk
FDA (Devices) · 2019-09-04
- HighQuantum Perfusion Systems CPB Roller Pumps Recalled for Mechanical Locking Defect
FDA (Devices) · 2024-10-30
- SevereSpectrum Medical Recalls Quantum PureFlow Heat Exchangers Due to Leak Risk
FDA (Devices) · 2026-10-07
- SevereBaxter Sigma Spectrum Infusion Pump Recall for Bearing Failure Risk
FDA (Devices) · 2012-06-20
- SevereBaxter Spectrum IQ Infusion Pumps Recalled Due to Potential Medication Delivery Failure
FDA (Devices) · 2022-02-09
- HighBaxter SPECTRUM Pump Recall Due to Service Technician Error
FDA (Devices) · 2014-10-08