Compliance EndoKit™ CEK-746Recalls & 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 00840253117113), received between Jul 7, 2026 and Jul 7, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COMPLIANCE ENDOKIT WAS BEING UNPACKED ON AN UNKNOWN DATE. UPON OPENING THE PRODUCT, A LIVE INSECT WAS FOUND INSIDE THE PACKAGING; THEREFORE, THE PRODUCT COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25740355 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.