Quantum ® QPF2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060434420756), received between Jan 28, 2025 and Jan 28, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Pumping Stopped” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K173834); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2025Pumping Stopped; Pumping Stopped

  DURING PROCEDURE, THE QUANTUM WORKSTATION SCREEN FROZE AND THE PERFUSIONIST WAS UNABLE TO ADJUST THE PUMPS. USER PERFORMED HARD REBOOT OF THE SYSTEM AFTER WHICH THE PUMPS STOPPED AND HAD TO BE HAND-CRANKED. THERE WAS NO PATIENT HARM. SPECTRUM MEDICAL CONSIDERS AN EVENT IN WHICH THE PUMP STOPS TO BE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21250070 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173834. One submission often covers many models, so check the product and lot details in each record.

• Z-0224-2025 · Mar 13, 2023 · Completed
  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) 51-0000
• Z-2238-2019 · May 29, 2019 · Terminated
  Quantum Pump Console