Halyard 95481Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651954814), received between Jun 23, 2017 and Jun 23, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Coiled” (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.

• MalfunctionJun 23, 2017Coiled; Coiled

  IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING SYMPTOMS FOR THE PAST FOUR TO FIVE DAYS. THE PATIENT WAS SENT TO HAVE AN X-RAY OF THE INTESTINAL TUBING FOR A POSSIBLE CLOG OR TO SEE IF THE TUBING HAD MOVED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED 25-MAY-2017 THAT STATED THAT THE PATIENT WAS ADMITTED TO THE ICU ON (B)(6) 2017. THE TUBING WAS DETERMINED TO BE MIC PEG AND J TUBING. THE TUBE WAS PLACED BETWEEN 10 DAYS AND FOUR WEEKS AGO, BY THE PHYSICIAN IN THE INTERVENTIONAL RADIOLOGY DEPARTMENT. THERE WERE NO REPORTED INJURIES. ON 02-JUN-2017, ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE TUBE WAS OBSERVED ON X-RAY TO BE COILED IN THE STOMACH AND WAS CONFIRMED BY THE PHYSICIAN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6663458 ↗