Shiley 4CN65RRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521205024), received between Oct 5, 2021 and Aug 3, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 reports).

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

1 other recall cover devices cleared under the same FDA submission (K150844); 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.

Recalls naming this device

1. Mar 24, 2023Open, Classified

   A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.

   Z-1357-2023 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Use of Device Problem

  Patient problems: Discomfort; Unintended Extubation

  MAUDE report 50124288 ↗
• MalfunctionJan 12, 2026Use of Device Problem

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE CUFF "RUPTURED" DURING ENDOTRACHEAL INTUBATION. A NEW  TRACHEOTOMY TUBE WAS USED AS A RE PLACEMENT.

  Patient problems: Unintended Extubation

  MAUDE report 24049681 ↗
• MalfunctionMay 8, 2025Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PRE USAGE TESTING, THE TRACH TUBE'S CUFF WAS NOT INFLATING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985994 ↗
• MalfunctionDec 30, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT, DURING USE, BOTH TRACHEOSTOMY TUBE'S CUFF HAD A LEAK, AS SHOWN IN THE VIDEO ATTACHED. BOTH TUBE WERE REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21034891 ↗
• MalfunctionDec 30, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT, DURING USE, BOTH TRACHEOSTOMY TUBE'S CUFF HAD A LEAK, AS SHOWN IN THE VIDEO ATTACHED. BOTH TUBE WERE REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21034849 ↗
• MalfunctionSep 24, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF OF THE TRACHEOSTOMY TUBE HAD A LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20289494 ↗
• MalfunctionSep 19, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, WHEN CHECKING THE FUNCTIONALITY OF THE TRACHEOSTOMY TUBE'S BALLOON, THE BALLOON WAS DEFECTIVE AND DID NOT SUSTAIN THE INFLATION THAT WAS INSERTED. REPLACEMENT OF THE ITEM WAS NECESSARY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20259098 ↗
• MalfunctionFeb 27, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF WAS NOT MAINTAINING INFLATION DURING PATIENT USE. A NURSE WAS CALLED FROM A HOSPITAL AND DID AN EMERGENCY TRACH CHANGE FOR THE PATIENT.

  Patient problems: Unintended Extubation

  MAUDE report 18791738 ↗
• MalfunctionJan 26, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE HAD INFLATION OR DEFLATION ISSUE. REPLACEMENT OF THE TUBE WAS DONE. THE OTHER TWO DEVICES WAS NOT USED WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 18586979 ↗
• MalfunctionOct 5, 2021Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE NEW TRACHES WERE FLEXIBLE, CLEAR, WITH A TAPERGUARD CUFF INSTEAD OF BARREL SHAPE CUFF, AND THE 15MM CONNECTOR WAS NOW ATTACHED TO THE FLANGE, NOT THE INNER CANNULA. THE TUMORS USUALLY BEING DEALT WITH COULD NOT HAVE FLEXIBLE MATERIALS AND ARE NOT APPLICABLE FOR PATIENTS WITH CHRONIC TRACHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576515 ↗
• MalfunctionOct 5, 2021Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE NEW TRACHES WERE FLEXIBLE, CLEAR, WITH A TAPERGUARD CUFF INSTEAD OF BARREL SHAPE CUFF, AND THE 15MM CONNECTOR WAS NOW ATTACHED TO THE FLANGE, NOT THE INNER CANNULA. THE TUMORS USUALLY BEING DEALT WITH COULD NOT HAVE FLEXIBLE MATERIALS AND ARE NOT APPLICABLE FOR PATIENTS WITH CHRONIC TRACHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576460 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150844. One submission often covers many models, so check the product and lot details in each record.

• Z-1390-2025 · Feb 26, 2025 · Open, Classified
  Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R