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Compliance EndoKit™ CEK-880Recalls & reported problems

Boston Scientific Corporation · Compliance EndoKit · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840253118257), received between Apr 30, 2019 and Apr 30, 2019 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Hypersensitivity/Allergic reaction1

Recent adverse event reports

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

  • InjuryApr 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COMPLIANCE ENDOKIT WAS USED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THE TECHNICIAN OPENED THE KIT, THERE WERE OVERWHELMING FUMES WHICH CAUSED THE TECHNICIAN TO HAVE AN ALLERGIC REACTION. THE TECHNICIAN WAS TAKEN TO THE EMERGENCY ROOM. IT IS UNKNOWN AS TO WHAT TREATMENT WAS GIVEN TO THE TECHNICIAN IN THE EMERGENCY ROOM HOWEVER THEY WERE REPORTED TO BE FINE AND STABLE FOLLOWING TREATMENT. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 8566835 ↗

Other ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE devices

All ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE devices →

Sources and updates

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