Compliance EndoKit™ KS-16Recalls & reported problems
Boston Scientific Corporation · Compliance EndoKit · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00840253119438), received between Jan 7, 2019 and Jan 7, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2019Device 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 AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, WHEN THE KIT WAS OPENED, THERE WAS A LONG HAIR INSIDE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8224168 ↗
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- VERIFY LCC101Steris Corporation · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK500FSAWMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK500FSMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK1000TSEMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK215FSMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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