Biodesign G23653Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002236530), received between Nov 14, 2023 and Nov 14, 2023 — classified as 1 malfunction.

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

• MalfunctionNov 14, 2023Material Separation; Material Separation

  ON (B)(6) 2023, A BIODESIGN ENTEROCUTANEOUS FISTULA PLUG WAS PLACED FOR REPAIR OF AN ENTEROCUTANEOUS FISTULA. THE PATIENT HAD THE ANAL CUTANEOUS FISTULA FOR OVER A YEAR. THE FISTULA EXITED OUT OF THE GLUTEUS. THERE WAS NO DISTAL OBSTRUCTION. THE PATIENT HAD NO HISTORY OF RECEIVING RADIATION. THE FISTULA DRAINED LESS THAN 20 ML/DAY. THE FISTULA TRACT WAS 11 CM IN LENGTH AND AROUND 2 MM IN DIAMETER. THERE WERE NO 4 MM PLUG SETS AVAILABLE AT THE IMPLANTING FACILITY. THE PHYSICIAN MADE THE DECISION TO IMPLANT A 7 MM PLUG. THE PLUG WAS SUCCESSFUL AT HEALING THE FISTULA HOWEVER, THE FLANGE WOULD NOT PASS ON ITS OWN WHICH CAUSED THE PATIENT TO EXPERIENCE PAIN. THE PAIN WAS NEAR THE PATIENT'S RECTUM AND OCCURRED WHEN PRESSURE WAS APPLIED. ON (B)(6) 2023, THE PHYSICIAN ATTEMPTED TO LAPAROSCOPICALLY REMOVE THE FLANGE. DUE TO THE LOCATION OF THE FLANGE,NEAR THE RECTUM RIGHT NEXT TO OR POSSIBLY ON THE SPHINCTER, THE FLANGE WAS REMOVED MANUALLY. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL COMPLICATIONS OR HARM. UPON EXAMINATION OF THE EXPLANTED FLANGE, THE PHYSICIAN NOTICES THAT THE SILICONE HAD PARTIALLY SEPARATED FROM THE NITINOL RING.

  Patient problems: Pain

  MAUDE report 18134912 ↗