Quantum QPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060434420763), received between Mar 4, 2026 and Mar 4, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Intermittent Loss of Power” (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.

• MalfunctionMar 4, 2026Intermittent Loss of Power

  WHILE ON BYPASS, THE ARTERIAL FLOW PROBE/BUBBLE IS INTERMITTENTLY GOING OFFLINE. THE OCCLUDER WAS SWAPPED YET THE ISSUE CONTINUED HAPPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510985 ↗

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