Shiley 10CN10RRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521205475), received between Dec 27, 2021 and Dec 3, 2024 — classified as 6 injuries, 10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE CANNULA INSERTED, BROKE THE CUFF ON THE MORNING WHERE THE TEAM OPTED TO INSERT A COMMON CANNULA DUE TO THE PATIENT'S SEVERITY AND RISKS.

  Patient problems: Unintended Extubation

  MAUDE report 20832904 ↗
• MalfunctionNov 27, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE CANNULA INSERTED SHOWED AIR LEAKAGE THROUGH THE CUFF, REQUIRING A NEW TRACHEAL MOLD UNTIL NEW INSERTION.

  Patient problems: Unintended Extubation

  MAUDE report 20801309 ↗
• MalfunctionNov 4, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, UPON INSERTION OF THE TRACHEOSTOMY CANNULA, IT WAS NOTED THAT THERE WAS AN AIR LEAKAGE SEEN IN THE CUFF. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20597502 ↗
• InjurySep 15, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE WAS DEFLATED PREMATURELY. THE PATIENT HAD TO CHANGE THE TRACH TUBE EVERY WEEK OR EVERY 15 DAYS INSTEAD OF ONCE A MONTH RESULTED TO DISCOMFORT. UPON VISUAL EXAMINATION, THE NURSE REPORTED THAT THE CUFF WAS 'WRINKLED' AND WHEN IT WAS INFLATED WITH SYRINGE, A PUNCTURED CUFF WAS OBSERVED.

  Patient problems: Discomfort; Unintended Extubation

  MAUDE report 20220984 ↗
• InjurySep 15, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE BALLOON OF THE TRACHEOSTOMY TUBE WAS DEFLATED PREMATURELY. THE PATIENT HAD TO CHANGE THE TRACH TUBE EVERY WEEK OR EVERY 15 DAYS INSTEAD OF ONCE A MONTH RESULTED TO DISCOMFORT. UPON VISUAL EXAMINATION, THE NURSE REPORTED THAT THE BALLOON WAS 'WRINKLED' AND WHEN IT WAS INFLATED WITH SYRINGE, A LEAKED BALLOON WAS OBSERVED.

  Patient problems: Discomfort; Unintended Extubation

  MAUDE report 20220973 ↗
• InjuryJan 10, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, BOTH TRACHEOSTOMY TUBE'S CUFF HAD A LEAK DURING PATIENT USE. THE PATIENT DESATURATED DOWN TO 70% DURING THE 3RD INSERTING TENTATIVE. TUBES WERE REPLACED TWICE FROM THE PATIENT.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 18486593 ↗
• MalfunctionJan 8, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, BOTH TRACHEOSTOMY TUBE'S CUFF HAD A LEAK DURING PATIENT USE. THE PATIENT DESATURATED DOWN TO 70% DURING THE 3RD INSERTING TENTATIVE. TUBES WERE REPLACED TWICE FROM THE PATIENT.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 18472372 ↗
• MalfunctionMay 9, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, PERFORMED SEVERAL EXCHANGES OF CANNULA BECAUSE THE CUFF WAS NOT KEPT INFLATED. AFTER TESTING IN A SINK WITH WATER, IT WAS NOTICED THAT THE CUFF HAD HOLES IN IT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16897993 ↗
• MalfunctionMay 9, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, PERFORMED SEVERAL EXCHANGES OF CANNULA BECAUSE THE CUFF WAS NOT KEPT INFLATED. AFTER TESTING IN A SINK WITH WATER, IT WAS NOTICED THAT THE CUFF HAD HOLES IN IT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16897650 ↗
• MalfunctionOct 20, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DEVELOPED CUFF LEAK. TRACHEOTOMY REQUIRED UNPLANNED REPLACEMENT WITH RESPIRATORY BACKUP AND ANESTHESIA. DEVICE CUFF WOULD NOT STAY INFLATED LEADING TO DEFLATION WHEN IT WAS TESTED AFTER IT WAS REMOVED.

  Patient problems: Unintended Extubation

  MAUDE report 15637364 ↗
• InjuryAug 10, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFFS WERE CHECKED PRIOR TO INSERTION BUT UNFORTUNATELY THEY BOTH POPPED ONCE INSERTED. PATIENT THEN NEEDED FURTHER SURGERY TO CONTROL BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Extubation

  MAUDE report 15202280 ↗
• InjuryJun 23, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFFS WERE CHECKED PRIOR TO INSERTION BUT UNFORTUNATELY THEY BOTH POPPED ONCE INSERTED. PATIENT THEN NEEDED FURTHER SURGERY TO CONTROL BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Extubation

  MAUDE report 14789674 ↗
• InjuryFeb 14, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE WAS INSERTED A DAY LATER OR SO DEVICE HAD A SLOW LEAK. AFTER INSPECTION, THE TRACH DID NOT SHOW ANY VISIBLE DAMAGE AND WILL HOLD AIR, HOWEVER, OVERTIME IT SLOWLY DEFLATED. IT WAS REPORTED THAT THERE WAS PATIENT HARM AS RESULT OF THE ISSUE.

  Patient problems: Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 13522742 ↗
• MalfunctionDec 27, 2021Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PHYSICIAN PLACED THE FIRST CANNULA BUT FIGURED OUT IMMEDIATELY AFTER PLACEMENT THAT THE CUFF WAS BROKEN. THE SAME WITH THE SECOND CUFF. BEFORE PLACING THE THIRD, THE PHYSICIAN INFLATED THE CUFF, AND AGAIN THE CUFF BROKE. A LEAK WAS FOUND. AFTER THIS, THE PHYSICIAN PLACED A SMALLER ONE, SIZE 8. UNTIL TODAY THERE ARE NO ISSUES.

  Patient problems: Unintended Extubation

  MAUDE report 13090688 ↗
• MalfunctionDec 27, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PHYSICIAN PLACED THE FIRST CANNULA BUT FIGURED OUT IMMEDIATELY AFTER PLACEMENT THAT THE CUFF WAS BROKEN AND THE SAME WITH THE SECOND CUFF. BEFORE PLACING THE THIRD, THE PHYSICIAN INFLATED THE CUFF, AND AGAIN THE CUFF BROKE. AFTER THIS, THE PHYSICIAN PLACED A SMALLER ONE, SIZE 8. UNTIL TODAY THERE ARE NO ISSUES.

  Patient problems: Unintended Extubation

  MAUDE report 13090679 ↗
• MalfunctionDec 27, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PHYSICIAN PLACED THE FIRST CANNULA BUT FIGURED OUT IMMEDIATELY AFTER PLACEMENT THAT THE CUFF WAS BROKEN AND THE SAME WITH THE SECOND CUFF. BEFORE PLACING THE THIRD, THE PHYSICIAN INFLATED THE CUFF, AND AGAIN THE CUFF BROKE. AFTER THIS, THE PHYSICIAN PLACED A SMALLER ONE, SIZE 8. UNTIL TODAY THERE ARE NO ISSUES.

  Patient problems: Unintended Extubation

  MAUDE report 13090594 ↗

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