Ballard* Closed Suction System 195-4JRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00609038993126), received between Nov 13, 2023 and Aug 12, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED, THE CATHETER WAS STUCK IN THE OPENING OF THE CARTRIDGE, WHILE IT COULD GET THROUGH THE OPENING, IT WAS VERY DIFFICULT TO PULL IN. THIS OCCURRED DURING USE; THERE WAS NO REPORTED INJURY. THE CATHETER WAS BLOCKED AT THE MANIFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22788688 ↗
• MalfunctionMar 25, 2025Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  IT WAS REPORTED, THE CATHETER WAS NOT SUCTIONING SMOOTHLY (IT FELT AS THOUGH IT WAS BLOCKED); THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692822 ↗
• MalfunctionMar 18, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED, SHORTLY AFTER USING THE DEVICE, THE CATHETER WAS BLOCKED AND DID NOT COME OUT FROM THE END; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634854 ↗
• MalfunctionDec 4, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED, THE CATHETER DID NOT COME OUT WHEN A HOSPITAL STAFF TRIED TO SUCTION THE PATIENT; THE CATHETER WAS REPLACED AND THE PATIENT WAS SUCTIONED NORMALLY. THERE WAS NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846399 ↗
• MalfunctionNov 17, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED, THE ON-SITE NURSE SUCCESSFULLY SUCTIONED [THE PATIENT] SEVERAL TIMES DURING INTUBATION; HOWEVER, WHEN ASPIRATION WAS PERFORMED, SUCTION DID NOT OCCUR. THE NURSE NOTED THERE WAS A WHITE FOREIGN SUBSTANCE IN THE CATHETER WHEN THE TIP (MARKER PART) OF THE CATHETER WAS CUT, THE CONTENTS WERE TAKEN OUT. THE NURSE ADDITIONALLY REPORTED, IT MAY BE A FOREIGN BODY THAT WAS ORIGINALLY IN THE PATIENT'S BODY, OR IT MAY BE SOME PART OF ANOTHER PRODUCT. THE DEVICE WAS REPLACED; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20702904 ↗
• MalfunctionJun 26, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED, THE 2.0 MM Y ADAPTER WAS CONNECTED TO THE 2.0 MM INTUBATION TUBE, BUT THE CATHETER DID NOT COME FROM THE TIP OF THE Y ADAPTER (THE CATHETER DID NOT ADVANCE), SO IT WAS REPLACED WITH A NEW PRODUCT. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19616453 ↗
• MalfunctionNov 13, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED, THE CATHETER DID NOT ADVANCE DURING SUCTIONING; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18122966 ↗