WallFlex™ Colonic M00565130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729456605), received between Apr 19, 2018 and Apr 19, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryApr 19, 2018Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX COLONIC STENT WAS IMPLANTED TO TREAT A 3 CM LESION IN THE COLON DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED IN THE TARGET LOCATION. HOWEVER, DURING THE REMOVAL OF THE DELIVERY SYSTEM, THE OUTER SHEATH OF THE DELIVERY SYSTEM WAS STUCK ON THE DISTAL END OF THE STENT. THE DELIVERY SYSTEM EVENTUALLY WAS ABLE TO BE REMOVED BUT AS A RESULT, THE DEPLOYED STENT SLID MORE DISTAL THAN THE DESIRED LOCATION. REPORTEDLY, THE PHYSICIAN WAS COMFORTABLE LEAVING THE WALLFLEX COLONIC STENT IMPLANTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT TO COVER THE ENTIRE STRICTURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7444946 ↗