Shiley 5CN70RRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884521205420), received between Apr 2, 2019 and Apr 24, 2026 — classified as 1 death, 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAD A PILOT BALLOON THAT FLATTENED AND WAS UNABLE TO INFLATE DURING A PRE-TEST. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987780 ↗
• MalfunctionDec 9, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS UNABLE TO INFLATED PROPERLY ON THE SECOND DAY OF PATIENT. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 23764150 ↗
• MalfunctionNov 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT, PRIOR TO USE, THE TRACHEOSTOMY TUBE EXHIBITED A CUFF INFLATION ISSUE AT A HOSPITAL. THERE WAS NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513733 ↗
• MalfunctionSep 9, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING SURGERY, THE CUFF OF THE TRACHEOSTOMY TUBE WAS FOUND TO BE LEAKING AIR. REPLACEMENT IF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 23000480 ↗
• MalfunctionAug 15, 2025Crack; Use of Device Problem; Crack; Use of Device Problem

  IT WAS REPORTED THAT THE TRACH TUBE'S INNER CANNULA WAS FOUND CRACKED AFTER NINE DAYS OF PATIENT USE, AS SHOWN IN THE ATTACHED IMAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815635 ↗
• MalfunctionApr 18, 2025Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864728 ↗
• InjuryApr 1, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE CANNULA WAS INSERTED, AIR LEAKAGE WAS FOUND AND EFFECTIVE VENTILATION COULD NOT BE MAINTAINED. THE T RACHEOSTOMY CANNULA WAS REPLACED IMMEDIATELY, WHICH PROLONGED THE OPERATION TIME.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 21738099 ↗
• MalfunctionMar 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY CANNULA'S CUFF WAS UNABLE TO INFLATE WHEN INFLATED. THE ISSUE TOOK PLACE IN A HOSPITAL SETTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21725882 ↗
• MalfunctionMar 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE HAD A LEAK, DAMAGE AND COULD NOT BE INFLATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618869 ↗
• MalfunctionMar 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USAGE, IT WAS FOUND THAT THE TRACHEOSTOMY TUBE'S CUFF WAS "RUPTURED", AS PER ATTACHED IMAGE THAT CAUSED AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559763 ↗
• MalfunctionMar 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY CANNULA'S CUFF HAD AN AIR LEAK THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528480 ↗
• MalfunctionNov 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE "DILATOR" 8.0 OF THE TRACHEOSTOMY TUBE WAS UNABLE TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663267 ↗
• MalfunctionAug 22, 2024Defective Component; Contamination /Decontamination Problem; Defective Component; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE HAD A MARK AND THE BEVELED TIP WAS NOT SMOOTH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038097 ↗
• MalfunctionAug 22, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE BEVELED TIP OF THE TRACHEOSTOMY TUBE WAS NOT SMOOTH, AS SHOWN IN THE PHOTO ATTACHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035807 ↗
• InjuryJul 12, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF DID NOT MAINTAIN INFLATED DURING THE PROCEDURE. THE TRACH WAS REPLACED.

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

  MAUDE report 19732917 ↗
• MalfunctionJul 24, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE HAD A LEAK DURING PATIENT USE. THE PATIENT HAD A REPLACEMENT TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 17381462 ↗
• InjuryApr 17, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD A LEAK AFTER LESS THAN TWENTY FOUR HOURS OF BEING USED. THE PATIENT HAD AN INCREASED RATE OF BREATHING AND A DROP IN OXYGEN LEVEL. ANOTHER BRAND OF TUBE WAS REPLACED FOR THE PATIENT TO RESOLVE THE ISSUE.

  Patient problems: Hypoventilation; Hypoxia; Low Oxygen Saturation; Respiratory Failure; Unintended Extubation

  MAUDE report 16753270 ↗
• InjuryOct 16, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT HAD TO EXCHANGE CANNULA ON THREE OCCASIONS FOR DAMAGE OF THE BALL. THE CANNULA BALLOON SHOWED A FISSURE THAT CAUSED LEAK AND IT WAS LOCATED IN THE AREA WHERE CANNULAS WERE CHANGE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Extubate

  MAUDE report 9197426 ↗
• InjuryOct 16, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT HAD TO EXCHANGE CANNULA ON THREE OCCASIONS FOR DAMAGE OF THE BALL. THE CANNULA BALLOON SHOWED A FISSURE THAT CAUSED LEAK AND IT WAS LOCATED IN THE AREA WHERE CANNULAS WERE CHANGE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Extubate

  MAUDE report 9197422 ↗
• DeathAug 7, 2019Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT HAD TO EXCHANGE CANNULA ON THREE OCCASIONS FOR DAMAGE OF THE BALL. IT HAD INFLATION AND DEFLATION ISSUE.

  Patient problems: Death; Extubate

  MAUDE report 8872379 ↗
• InjuryJun 19, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT LARYNGECTOMY. POST-OPERATIVELY, THE DEVICE'S CUFF HAD AIR LEAKAGE DURING SECOND DAY OF INSERTION. THE DEVICE WAS REMOVED FROM THE PATIENT AND RE-CANNULATION WAS PERFORMED.

  Patient problems: Extubate

  MAUDE report 8712736 ↗
• MalfunctionApr 2, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF INFLATION/DEFLATION ISSUE WHICH INVOLVES CUFF, PILOT BALLOON AND PILOT LINE. IT WAS INDICATED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8476258 ↗

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