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Compliance EndoKit™ CEK-799Recalls & 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 00840253117489), received between Nov 26, 2018 and Nov 26, 2018 — 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.

  • MalfunctionNov 26, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COMPLIANCE ENDOKIT WAS USED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, WHEN THE KIT WAS OPENED, THERE WAS A SMALL BUG INSIDE THE PACKAGE. THE KIT WAS DISPOSED AND ANOTHER COMPLIANCE ENDOKIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8102482 ↗

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.