Spectrum Medical recalls Quantum Perfusion Systems for CPB roller pumps due to left bobbin lock failure. Affected units have specific serial numbers and catalog codes. Contact for remedy.
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
Spectrum Medical is recalling Quantum Perfusion Systems for CPB roller pumps because the left bobbin won't lock properly. This could cause blood flow issues during surgery if the pump fails.
The ratchet and pawl mechanism has an out-of-tolerance geometry that prevents the left bobbin from locking. This could cause blood flow interruptions during surgery if the pump fails to maintain pressure.
Healthcare professionals using these pumps in cardiac surgery or critical care settings. Patients undergoing procedures with these pumps are at risk if the pump malfunctions.
Check for catalog numbers 51-000013-00 or 51-000008-00. Serial numbers starting with AU6004 or AU8001 are affected. The UDI/DI code 05060434420770 identifies the recall batch.
Verify your pump's catalog number and serial number against the listed affected models.
The ratchet and pawl mechanism has an out-of-tolerance geometry that prevents the left bobbin from locking, potentially causing blood flow interruptions during surgery.
Check for catalog numbers 51-000013-00 or 51-000008-00 and serial numbers starting with AU6004 or AU8001. The UDI/DI code 05060434420770 identifies the recall batch.
The recall record does not specify a remedy, so contact Spectrum Medical directly for guidance.
We’ve drafted a message you can send Spectrum Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0224-2025 — Spectrum Medical Spectrum Medical Hello, I own a Spectrum Medical that is covered by recall Z-0224-2025 from Spectrum Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
