Shiley 8DCPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 40884522005310), received between Jan 20, 2023 and Jan 20, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K843730); they may or may not involve this specific model.

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

Recent adverse event reports

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

• MalfunctionJan 20, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE PLUG WOULD NOT FIT IN THE TRACH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16216020 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K843730. One submission often covers many models, so check the product and lot details in each record.

• Z-2653-2026 · Apr 23, 2026 · Open, Classified
  Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number