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Compliance EndoKit™ CEK-876Recalls & reported problems

Boston Scientific Corporation · Compliance EndoKit · Class 1

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 00840253118219), received between Feb 12, 2020 and Feb 12, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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

  • Device Contaminated During Manufacture or Shipping1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionFeb 12, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COMPLIANCE ENDOKIT WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION IT WAS NOTED THAT HUMAN HAIR WAS FOUND INSIDE THE SEALED KIT PACKAGE. ANOTHER COMPLIANCE ENDOKIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9699245 ↗

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.