Halyard 94884Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651948844), received between Mar 16, 2017 and Mar 16, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2017Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED BY THE HOME HEALTH NURSE THAT, "THE BALLOON ON THE TUBE PLACED SIX MONTHS AGO WILL NOT DEFLATE. A PAPER CLIP WAS USED WITHOUT SUCCESS SO AN ATTEMPT WAS MADE TO OVER-INFLATE TO BURST BALLOON TO ENABLE REMOVAL OF THE TUBE. AN APPOINTMENT HAD BEEN SCHEDULED WITH THE OSTOMY NURSE FOR THE PATIENT." THERE WERE NO INJURIES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 02-MAR-2017 THAT STATES, "THE WATER WOULD NOT COME OUT OF THE BALLOON TO REMOVE THE DEVICE. THE GI OSTOMY NURSE CUT THE DEVICE AT THE ABDOMEN TO RELEASE THE WATER SO THE PATIENT COULD EXCRETE THE BALLOON. THE PATIENT DID ELIMINATE THE BALLOON. THE OSTOMY NURSE SAID PORT WAS CLOGGED." ANOTHER LIKE TUBE WAS REPLACED ON THE PATIENT. THERE WERE NO INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6411969 ↗