Halyard 10237Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651102376), received between May 4, 2017 and May 4, 2017 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 4, 2017Break; Break

  IT WAS INITIALLY REPORTED THAT 3 OF 4 T-FASTENER SUTURES BROKE ABOUT 1CM BELOW LOCKING BOLSTER. THE BALLOON RETAINED INTERNAL GASTRONOMY-TUBE BUMPER AND WAS FOUND TO BE OUTSIDE THE STOMACH, IN THE ABDOMEN. THE PATIENT RETURNED TO THE OPERATING ROOM FOR AN OPEN LAPAROTOMY. THE PHYSICIAN ALLEGED THE PATIENTS STOMACH WAS NOT INSUFFLATED FOR THE PROCEDURE AND MOST LIKELY LED TO COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED ON 12-APR-2017 THAT STATES, THE PROCEDURE WAS PERFORMED FRIDAY, (B)(6) 2017. ON SATURDAY OR SUNDAY (EXACT DATE UNKNOWN) THE T-FASTENERS BROKE AND THE PATIENT HAD A CAT SCAN. THE G-TUBE WAS FOUND TO BE IN THE PERITONEAL CAVITY. THE FEEDING TUBE WAS ALLEGED NOT TO BE USED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A LAPAROTOMY TO HAVE THE TUBE REMOVED. THE FEEDING TUBE WAS COMPLETELY INTACT AND THERE WERE NO ISSUES WITH THE FEEDING TUBE ITSELF. THE SURGEON DID NOT INFLATE THE STOMACH DURING PROCEDURE/PLACEMENT OF T-FASTENERS. THE PATIENT IS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6545446 ↗