Quantum Perfusion Systems CPB Roller Pumps Recalled for Mechanical Locking Defect
Spectrum Medical Ltd. is recalling 172 Quantum Perfusion Systems CPB Roller Pumps due to an out-of-tolerance ratchet and pawl defect preventing proper bobbin locking. This defect may affect blood circulation control during cardiac surgery.
What this means for you
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: This is an FDA Class II device with a documented manufacturing defect in critical surgical equipment. Although no adverse events are reported in the source, the defect—out-of-tolerance ratchet and pawl geometry preventing proper bobbin locking—could compromise blood circulation control during open-heart surgery. Per the severity rubric, FDA Class II recalls with no reported illnesses score at most High (3).
Plain-English summary
Spectrum Medical Ltd. is recalling 172 Quantum Perfusion Systems for Cardiopulmonary Bypass (CPB) Roller Pumps with catalog numbers 51-000013-00 and 51-000008-00. The recall affects units with specific serial numbers and UDI/DI 05060434420770, distributed nationwide across 18 US states.
The recalled pumps have a manufacturing defect in the ratchet and pawl assembly. The ratchet and pawl geometry is out of specification, causing the left bobbin to fail to lock properly. This mechanical defect could impair the pump's ability to control blood flow through the venous and arterial circuit tubing during open-heart surgery.
The affected devices have been distributed to medical facilities nationwide, including hospitals in Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, and West Virginia. Patients who have undergone cardiopulmonary bypass surgery using these pumps may be at risk.
Healthcare providers who have received these pumps should identify affected units by serial number, discontinue use, and contact the manufacturer or FDA for replacement or repair instructions. Patients who underwent cardiac surgery using these pumps should consult their healthcare provider about the potential risk.
The recalled product
- Product
- Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
- Manufacturer
- Spectrum Medical Ltd.
- Hazard
- mechanical-failure
- device-malfunction
- blood-flow-control
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 (20)
- UDI/DI 05060434420770: Serial Numbers: a) AU6004040
- AU6004041
- AU6004042
- AU6004043
- AU6004044
- AU6004046
- AU6004050
- AU6004051
- AU6004052
- AU6004053
- AU6004054
- AU6004056
- AU6004057
- AU6004058
- AU6004060
- AU6004061
- AU6004062
- AU6004063
- AU6004064
- AU6004065
Distribution
Distributed nationwide across the United States.
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