Ballard* Closed Suction System for Adults 94492Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00609038944920), received between Jul 6, 2022 and Sep 24, 2024 — classified as 3 malfunctions.

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

Recalls naming this device

1. Mar 19, 2025Class IOpen, Classified

   Lack of sterility assurance for closed suction catheter systems

   Z-1524-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionSep 24, 2024Material Integrity Problem; Material Integrity Problem

  AN ISSUE WITH A CRACKED BALLARD WAS REPORTED; THERE WAS NO REPORT OF INJURY. ADDITIONAL INFORMATION RECEIVED 03SEP2024 REPORTED, DURING A ROUTINE ASSESSMENT THE STAFF NOTICED THE PRODUCT SEEMED TO BE ¿SHATTERED¿. THE RESPIRATORY THERAPIST (RT) SWAPPED OUT THE DEVICE AND REPLACED IT WITH A NEW ONE. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294523 ↗
• MalfunctionDec 8, 2022Suction Failure; Suction Failure

  IT WAS REPORTED ¿IT WAS REMOVED FROM A DEFECTIVE TRACHEOSTOMY SUCTION SYSTEM WITH A BROKEN PART (SUCTION).¿ THERE WAS NO REPORTED INJURY. IT WAS ADDITIONALLY REPORTED, THE PATIENT¿S CONDITION WAS DUE TO TRAVELING BY BICYCLE (ON (B)(6) 2022) AT A HIGH SPEED WITHOUT PROTECTIVE EQUIPMENT AND PRESENTED WITH A FALL AND DIRECT CONTUSION ON THE SKULL AND THEY WERE TRANSFERRED TO THE EMERGENCY DEPARTMENT OF ANOTHER HOSPITAL UNIT. AN EPIDURAL HEMATOMA OF 20 MM WAS DETECTED IN THE RIGHT PARIETAL POLE THAT COMPRESSES PARENCHYMA, IT WAS ASSESSED BY NEUROSURGERY AND ADVANCED MANAGEMENT OF THE AIRWAY WAS PLACED AS WELL AS ADMISSION TO THE OPERATING ROOM FOR DRAINAGE OF THE EPIDURAL HEMATOMA. ADDITIONAL INFORMATION RECEIVED 16NOV20202 REPORTED, THE DEVICE DID NOT SUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15946460 ↗
• MalfunctionJul 6, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THE CLINICIAN "WAS SUCTIONING THE PATIENTS...AS USUAL WITH [THE CLINICIAN] 11 AM VENT CHECK/ PATIENT ASSESSMENT. NO PROBLEMS INSERTING THE INLINE SUCTION CATHETER AT ALL BUT WHEN [THE CLINICIAN] ATTEMPTED TO PULL BACK THE SUCTION CATHETER AND BEGIN THE SUCTION PROCESS [THE CLINICIAN] NOTICED THE CLEAR SHEATH WITHDREW BUT THE CATHETER WAS NOT ATTACHED. THEREFORE, [THE CLINICIAN] NEEDED TO GRAB ONTO THE SUCTION CATHETER WHICH [THE CLINICIAN] COULD SEE AT THE BASE OF THE ETT (ENDOTRACHEAL TUBE) AND PULL BACK TO REMOVE IT FROM THE AIRWAY. THIS WAS DONE THE BROKEN INLINE CATHETER WAS REMOVED AND A NEW SUCTION CATHETER WAS PLACED INLINE. NO HARM TO PATIENT, VITALS ALL REMAINED STABLE WITH GOOD AERATION AND EQUAL BILATERAL BS (BREATH SOUNDS) NOTED."

  Patient problems: Insufficient Information

  MAUDE report 14940636 ↗