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WallFlex™ Colonic M00565140Recalls & reported problems

Boston Scientific Corporation · Stent System with Anchor Lock Delivery System · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729456612), received between Nov 17, 2021 and Nov 17, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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

Device problems

  • Activation, Positioning or Separation Problem1
  • Appropriate Device Problem Term/Code Not Available1
  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 17, 2021Break; Activation, Positioning or Separation Problem; Appropriate Device Problem Term/Code Not Available; Break; Activation, Positioning or Separation Problem; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED TO TREAT A 7CM MALIGNANT STRICTURE IN THE SIGMOID COLON DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, UPON DEPLOYING THE STENT, THE OUTER SHEATH BROKE AND THE STENT WAS UNABLE TO DEPLOY COMPLETELY. THE STENT WAS PARTIALLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESCHEDULED AND COMPLETED THE NEXT DAY DUE TO DEVICE AVAILABILITY OF A LONGER STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12828311 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.