Halyard 44292Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10680651442922), received between Apr 12, 2019 and Oct 17, 2019 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS AN UNEXPECTED DISCONNECTION OF AN INTRODUCER PART DURING A RADIOLOGICAL PERCUTANEOUS GASTROSTOMY PROCEDURE. WHEN REMOVING THE GUIDEWIRE FROM THE INTRODUCER, THE DILATOR OF THE INTRODUCER REMAINED INSIDE THE PATIENT'S STOMACH, WITHOUT MEANS TO RECOVER IT. AN ABDOMINAL-PELVIC CT SCAN SHOWED THE PRESENCE OF A 15CM INTRA-GASTRIC FOREIGN BODY. THERE WAS NO IMMEDIATE CLINICAL CONSEQUENCE TO THE PATIENT. THE PATIENT WAS TRANSFERRED TO ENDOSCOPY FOR REMOVAL OF THE FOREIGN BODY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9204338 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "ON CLINICAL EXAMINATION, ERYTHEMA AROUND THE GASTROSTOMY ORIFICE WITH INDURATION SUGGESTIVE OF A WALL ABSCESS. WALL ULTRASONOGRAPHY FOUND SUBCUTANEOUS INFILTRATION BUT WITHOUT VISUALIZED ABSCESS." PRODUCT WAS IN USE FOR TWO MONTHS. ANTIBIOTICS WERE REQUIRED AS MEDICAL TREATMENT. PATIENT'S CURRENT STATUS WAS LISTED AS "HE'S FINE."

  Patient problems: Abscess; Erythema

  MAUDE report 9010123 ↗
• InjurySep 10, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  PER ADDITIONAL INFORMATION RECEIVED ON 30 SEP 2019, THE DEVICE HAD BEEN IN PLACE FOR TWO MONTHS.

  Patient problems: No Code Available

  MAUDE report 8982742 ↗
• MalfunctionApr 12, 2019Break; Break

  IT WAS REPORTED THAT DURING A BANDAGE CHANGE, THE FEEDING TUBE WAS SEVERED, THE BALLOON DEFLATED, AND "THE PROBE FELL." THE BANDAGE CHANGE HAD BEEN DONE ACCORDING TO THE HOSPITAL'S PROCESS. THE TUBE HAD BEEN PLACED ON (B)(6) 2019. NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8509111 ↗