Vital Signs™ 1552016 (UDI 10889483573624)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889483573624), received between Jun 13, 2025 and Jul 16, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT THE CIRCUITS ROUTINELY FAIL DURING NEONATAL SURGICAL PROCEDURES AND FILTER GETS CLOGGED. WHILE NO PATIENT HARM OR INJURY WAS REPORTED, THE FAILURE OF THE CIRCUIT, WHICH LEAD TO CLOGGING OF THE CIRCUIT LINE COULD CAUSE OR LEAD TO A DELAY OR STOPPAGE OF THE THERAPY TO THE PATIENT, SHOULD THE ISSUE REOCCUR AND COULD RESULT IN A SERIOUS INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22525786 ↗
• MalfunctionJun 13, 2025Connection Problem; Connection Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030673-2025-00017 FOR THE FIRST REPORT. IT WAS REPORTED, THE HOSE WHICH WAS CONNECTED TO THE PRODUCTS' Y-PIECE DISCONNECTED DURING USE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205555 ↗
• MalfunctionJun 13, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030673-2025-00018 FOR THE SECOND REPORT. IT WAS REPORTED, THE HOSE WHICH WAS CONNECTED TO THE PRODUCTS' Y-PIECE DISCONNECTED DURING USE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205554 ↗