Quantum QSOL (REF 51-000022-00)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05060434420732), received between Dec 12, 2024 and Feb 3, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Unintended Movement

  THIS ISSUE RELATES TO AN OCCLUDER OPENING TWICE DURING SURGERY WITHOUT REQUEST. THE DEVICE IS BEING RETURNED AND AN INVESTIGATION IS ONGOING INTO THIS PROBLEM. ALTHOUGH, THERE WAS NO PATIENT HARM OR DELAY TO SURGERY.THIS EVENT IS DEEMED REPORTABLE BY SPECTRUM MEDICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244558 ↗
• MalfunctionDec 12, 2024Loose or Intermittent Connection; Pumping Stopped; Loose or Intermittent Connection; Pumping Stopped

  USER NOTICED ARTERIAL FLOW WAS UNAVAILABLE. THIS PROMPTED THE USER TO MOVE BUBBLE AND FLOW SENSORS. USER ATTEMPTED TO DISABLE BUBBLE ALARM PRIOR TO MOVING BUT DUE TO A SUSPECTED CONNECTION ISSUE BUBBLE ALARM REMAINED PRIMED. ON MOVING THE BUBBLE SENSOR, BUBBLE ALARM TRIGGERED CAUSING OCCLUDER TO CLOSE AND PUMP TO STOP. USER FOLLOWED RISK COTROLS AND RESUMED BYPASS 40 SECONDS AFTER CESSATION. THERE WAS NO HARM TO THE PATIENT. SPECTRUM MEDICAL CONSIDERS PUMP STOP A REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914129 ↗