Shiley 7CN80ARecalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10884521172487), received between Jul 16, 2018 and Aug 31, 2026 — classified as 3 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Defective Component” (38 reports).

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. 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 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Patient-Device Incompatibility

  It was reported that during the patient¿s agitation, the tracheostomy tube slipped out of the trachea, resulting in tracheostomy tube displacement which caused an insufficient ventilation. The otolaryngology department and anesthesiology department were immediately called for bedside rescue, and an otolaryngologist inserted the tracheostomy tube under fiberoptic bronchoscopy.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 50532334 ↗
• InjuryAug 31, 2026Human-Device Interface Problem

  It was reported that intra-operatively, after the patient coughed, the ventilator showed a low tidal volume, and an air leak sound was heard from the mouth and nose. Inspection of the circuit showed no abnormalities. The suction catheter could be inserted smoothly to 20 cm. The tracheostomy cuff had low tension, and after inflation it leaked repeatedly. The patient was tachypneic, but auscultation showed symmetric breath sounds in both lungs, with no obvious three-concave sign and no subcutaneous emphysema. Peripheral oxygen saturation fluctuated between 95% and 98%. Airway tube displacement and cuff leakage were considered possible. Assisted oral ventilation with a resuscitation bag was provided, and otolaryngology was asked to replace the tube with a longer one at the bedside. The patient¿s vital signs remained stable.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 50532150 ↗
• MalfunctionMar 12, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE TRACHEOSTOMY TUBE'S CUFF DID NOT STAY INFLATED. THE DEVICE FAILURE RESULTED IN A EXTENDED PROCEDURE TIME, AND THE PATIENT WAS REINTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 24582263 ↗
• MalfunctionMar 3, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE TRACHEOSTOMY TUBE'S CUFF EXHIBITED LEAKAGE DURING TESTING IN A HOSPITAL SETTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501350 ↗
• MalfunctionFeb 25, 2026Use of Device Problem

  IT WAS REPORTED THAT AIR LEAKAGE WAS FOUND IN THE CUFF WHEN THE BALLOON WAS INFLATED WITH 25 CM H2O IN SALINE PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449266 ↗
• MalfunctionNov 21, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN THE ON-DUTY DOCTOR WAS CONSULTING AND REPLACING THE PATIENT'S 8.0 TRACHEOSTOMY TUBE, IT WAS FOUND THAT THE CUFF OF THE TRACHEOSTOMY TUBE COULD NOT BE INFLATED. THE TRACHEOSTOMY TUBE WAS REPLACED AGAIN.

  Patient problems: Unintended Extubation

  MAUDE report 23618002 ↗
• MalfunctionAug 12, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE INNER DIAMETER OF THE FOUR TRACHEOSTOMY TUBES FAILED DURING INTERNAL DIAMETER TESTING IN THE FACILITY INSPECTION. IT WAS ALSO STATED THAT THE MIDDLE SECTION STILL FAILED, WHILE THE TIP END BARELY PASSED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790383 ↗
• MalfunctionAug 12, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE INNER DIAMETER OF THE FOUR TRACHEOSTOMY TUBES FAILED DURING INTERNAL DIAMETER TESTING IN THE FACILITY INSPECTION. IT WAS ALSO STATED THAT THE MIDDLE SECTION STILL FAILED, WHILE THE TIP END BARELY PASSED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790380 ↗
• MalfunctionAug 12, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE INNER DIAMETER OF THE FOUR TRACHEOSTOMY TUBES FAILED DURING INTERNAL DIAMETER TESTING IN THE FACILITY INSPECTION. IT WAS ALSO STATED THAT THE MIDDLE SECTION STILL FAILED, WHILE THE TIP END BARELY PASSED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790378 ↗
• MalfunctionAug 12, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE INNER DIAMETER OF THE FOUR TRACHEOSTOMY TUBES FAILED DURING INTERNAL DIAMETER TESTING IN THE FACILITY INSPECTION. IT WAS ALSO STATED THAT THE MIDDLE SECTION STILL FAILED, WHILE THE TIP END BARELY PASSED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790368 ↗
• MalfunctionAug 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING; TWO TRACH TUBE'S CUFF HAD AN AIR LEAK CONSECUTIVELY. THE CUFF WAS INFLATED TO A PRESSURE OF 25CMH2O, IT WAS PLACED IN NORMAL SALINE FOR INSPECTION AND BUBBLES WERE FOUND. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22718756 ↗
• MalfunctionAug 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING; TWO TRACH TUBE'S CUFF HAD AN AIR LEAK CONSECUTIVELY. THE CUFF WAS INFLATED TO A PRESSURE OF 25 CMH2O, IT WAS PLACED IN NORMAL SALINE FOR INSPECTION AND BUBBLES WERE FOUND. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22718488 ↗
• MalfunctionNov 27, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE HAD UNKNOWN FAILURE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Dyspnea; Unintended Extubation

  MAUDE report 20802471 ↗
• MalfunctionSep 9, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-TEST INSPECTION, BOTH OF THE TRACHEOSTOMY TUBES' CUFFS HAD AIR LEAKS AFTER INFLATING AND PLACED IN NORMAL SALINE, WHEREIN BUBBLES WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20167460 ↗
• MalfunctionJan 3, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AFTER OPENING THE PACKAGE AND PLACED IN PATIENT'S USE SITE, A CUFF AIR LEAK WAS FOUND AFTER INFLATION. THERE WAS REQUIRED TUBE REPLACEMENT.

  Patient problems: Unintended Extubation

  MAUDE report 16086761 ↗
• MalfunctionDec 7, 2022Gas/Air Leak; Insufficient Device Problem Information; Gas/Air Leak; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, AFTER OPENING THE PACKAGE AND PLACED IN PATIENT'S USE SITE, A CUFF AIR LEAK FOUND AFTER INFLATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934289 ↗
• MalfunctionDec 7, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AFTER OPENING THE PACKAGE AND PLACED IN PATIENT'S USE SITE, A CUFF AIR LEAK FOUND AFTER INFLATION. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 15934254 ↗
• MalfunctionOct 18, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE WAS A DIMENSION ISSUE WITH THE TRACH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621467 ↗
• MalfunctionOct 17, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE WAS A DIMENSION ISSUE WITH THE TRACH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620606 ↗
• MalfunctionOct 17, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE WAS A DIMENSION ISSUE WITH THE TRACH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620567 ↗
• MalfunctionOct 17, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE WAS A DIMENSION ISSUE WITH THE TRACH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620544 ↗
• MalfunctionOct 17, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE WAS A DIMENSION ISSUE WITH THE TRACH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620510 ↗
• MalfunctionOct 17, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE WAS A DIMENSION ISSUE WITH THE TRACH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620397 ↗
• MalfunctionOct 17, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE WAS A DIMENSION ISSUE WITH THE TRACH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620363 ↗
• MalfunctionOct 17, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE WAS A DIMENSION ISSUE WITH THE TRACH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620244 ↗