Shiley 4DCPRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 40884522005235), received between Nov 12, 2018 and Nov 12, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2018Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE DEVICE¿S PLUG WOULD NOT HOLD AND KEPT FALLING OUT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8061521 ↗
• MalfunctionNov 12, 2018Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE DEVICE¿S PLUG WOULD NOT HOLD AND KEPT FALLING OUT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8061489 ↗
• MalfunctionNov 12, 2018Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE DEVICE¿S PLUG WOULD NOT HOLD AND KEPT FALLING OUT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8061446 ↗
• MalfunctionNov 12, 2018Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE DEVICE¿S PLUG WOULD NOT HOLD AND KEPT FALLING OUT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8061424 ↗
• MalfunctionNov 12, 2018Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE DEVICE¿S PLUG WOULD NOT HOLD AND KEPT FALLING OUT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8061382 ↗

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