BALLARD™ 1222Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10889483563243), received between May 6, 2026 and May 21, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Suction Failure

  IT WAS REPORTED THAT THE BALLARD ORAL CARE PEDIATRIC CATHETER DID NOT PROVIDE SUCTION DURING PATIENT USE. THERE WAS NO NEGATIVE PATIENT OUTCOME; HOWEVER, THE ISSUE WAS CONSIDERED INCONVENIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242630 ↗
• MalfunctionMay 6, 2026Suction Failure

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2026-00025 FOR THE FIRST REPORT REFER TO 8030647-2026-00026 FOR THE SECOND REPORT. IT WAS REPORTED, THE INFANT NEEDED ORAL SUCTION; HOWEVER, WHEN ATTACHED THE BALLARD CLOSED SUCTION CATHETER (CSC) WOULD NOT SUCTION, THE CSC WAS EXCHANGED, A DIFFERENT LOT NUMBER WAS USED AND THE PRODUCT FUNCTIONED CORRECTLY. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107206 ↗
• MalfunctionMay 6, 2026Suction Failure

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2026-00026 FOR THE SECOND REPORT. REFER TO 8030647-2026-00027 FOR THE THIRD REPORT. IT WAS REPORTED, THE INFANT NEEDED ORAL SUCTION; HOWEVER, WHEN ATTACHED THE BALLARD CLOSED SUCTION CATHETER (CSC) WOULD NOT SUCTION, THE CSC WAS EXCHANGED. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107085 ↗
• MalfunctionMay 6, 2026Suction Failure

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 8030647-2026-00025 FOR THE FIRST REPORT. REFER TO 8030647-2026-00027 FOR THE THIRD REPORT. IT WAS REPORTED, THE INFANT NEEDED ORAL SUCTION; HOWEVER, WHEN ATTACHED THE BALLARD CLOSED SUCTION CATHETER (CSC) WOULD NOT SUCTION, THE CSC WAS EXCHANGED. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY AS A RESULT OF THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107077 ↗