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Compliance EndoKit™ CEK-721Recalls & reported problems

Boston Scientific Corporation · Compliance EndoKit · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840253116932), received between Feb 15, 2018 and Feb 15, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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

  • Break2

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 15, 2018Break

    ENDOCHOISE COMPLIANCE ENDOKIT HEDGEHOG DUAL END BRUSH REF CEK-721-20 LOT 205644 EXP 08/2019. BRUSH END BROKE OFF AND REMAINED LODGED IN ENDOSCOPE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7276141 ↗
  • InjuryFeb 15, 2018Break

    BRUSH HEAD BROKE OFF AND WAS LODGED IN ENDOSCOPE, THIS IS THE SECOND (FORMERLY REPORTED TO MANAGEMENT AND DOCUMENTED) OCCURRENCE WITH THIS PRODUCT, BUT IT HAD HAPPENED SEVERAL TIMES PREVIOUS, BUT WAS DISCOVERED AND REMOVED FROM THE SCOPE BEFORE GOING INTO HDL PROCESSOR. WE DO NOT HAVE THE SPECIFIC PIECES AVAILABLE, THEY WERE PUT INTO THE TRASH.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7276130 ↗

Other Accessories, Cleaning Brushes, For Endoscope devices

All Accessories, Cleaning Brushes, For Endoscope devices →

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