Ballard* Closed Suction System 196-4JRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00609038993140), received between Oct 12, 2023 and Apr 30, 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.

• MalfunctionApr 30, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING PATIENT USE, REPEATED DETACHMENT OF THE IRRIGATION PORT WAS OBSERVED. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050130 ↗
• MalfunctionOct 12, 2023Material Integrity Problem; Material Integrity Problem

  THE DISTAL END OF THE Y-ADAPTOR BROKE WHEN INTUBATING THE DEVICE INTO THE PATIENT'S NASAL CAVITY; THE DEVICE BROKE AT THE TIP AND WAS REPORTED TO STILL BE IN THE PATIENT'S NOSE. THE CATHETER HAD BEEN IN USE FOR 48 HOURS; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023 REPORTED, THE CLOSED SUCTION CATHETER (CSC) HAD BEEN IN USE SINCE (B)(6) 2023; HOWEVER, THE AFFECTED Y-ADAPTER (3.0), WITH 3.0MM MICROCUFF, HAD BEEN IN USE SINCE (B)(6) 2023 (OVER 2 WEEKS); THE CSC AS WELL AS THE MICROCUFF WERE USED NASALLY. IT WAS ADDITIONALLY REPORTED, WHEN THE Y-ADAPTER BROKE THE BROKEN TIP DROPPED ONTO THE PATIENT¿S FACE AND DID NOT ENTER THE PATIENT¿S BODY (AS WAS PREVIOUSLY REPORTED). IT WAS NOTED, "THERE WAS NO EFFECT ON THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17923842 ↗