Ballard* Closed Suction System 93834Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00609038938349), received between Mar 10, 2022 and May 6, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Suction Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 19, 2025Open, Classified

   Lack of sterility assurance for closed suction catheter systems

   Z-1522-2025 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionMay 6, 2022Suction Problem; Suction Problem

  IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER (CSC) DID NOT SUCTION DURING USE. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14306015 ↗
• InjuryMar 10, 2022Suction Problem; Suction Problem

  IT WAS REPORTED THE THUMB VALVE ON THE CLOSED SUCTION CATHER (CSC) REMAINED IN THE DOWN POSITION AFTER SUCTIONING; THE CSC HAD BEEN IN PLACE FOR 12-HOURS. DURING THE INCIDENT THE PATIENT'S OXYGEN LEVEL DECREASED TO 70%. THE CSC WAS REPLACED WITH A NEW ONE AND THE PATIENT¿S OXYGEN LEVELS INCREASED UNTIL THE OXYGEN SATURATION IMPROVED. AT THE TIME OF THE REPORT, THE PATIENT REMAINED IN CRITICAL CONDITION WITH NO FURTHER COMPLICATIONS DUE TO THE REPORTED CSC EVENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 13726939 ↗