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Shiley DDCPRecalls & reported problems

Covidien LP · Decannulation Plug,Disposable · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 40884522004061), received between Aug 19, 2022 and Aug 19, 2022 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Apr 23, 2026Open, Classified

    Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

    Z-2653-2026 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Device problems

  • Use of Device Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionAug 19, 2022Use of Device Problem; Use of Device Problem

    ACCORDING TO THE REPORTER, DURING USE, THE CUFF LESS TRACH PLUG WAS NOT STAYING PLUGGED IN THE TRACH. THERE WAS NO REPORTED PATIENT OUTCOME.

    Patient problems: Insufficient Information

    MAUDE report 15260075 ↗

Other Tube, tracheostomy (w/wo connector) devices

All Tube, tracheostomy (w/wo connector) devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page