Shiley 5CN70HRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20884521176314), received between Oct 16, 2019 and Apr 21, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S CUFF RUPTURED. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24942764 ↗
• MalfunctionApr 21, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S CUFF RUPTURED AND DID NOT INFLATE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24942657 ↗
• MalfunctionSep 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY CANNULA'S PILOT BALLOON HAD SECRETIONS IN IT. A BIVONA WAS PLACED.

  Patient problems: Unintended Extubation

  MAUDE report 23089546 ↗
• MalfunctionSep 12, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE TRACHEOSTOMY CANNULA HAD A CUFF PIN HOLE. THE SAME KIND OF TRACH WAS PLACED INSIDE THE PATIENT.

  Patient problems: Unintended Extubation

  MAUDE report 23042859 ↗
• MalfunctionDec 4, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S CUFF WAS FAULTY AND BALLOONED OUT AND DID NOT SEAL CORRECTLY. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20847603 ↗
• MalfunctionSep 20, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT REQUIRED FIVE TRACH CHANGES IN SEVEN DAYS, AND UPON INSPECTION THE TRACHEOSTOMY TUBE'S CUFF WAS LEAKING AT THE POINT WHERE THE PILOT BALLOON LINE ENTERED THE CUFF DURING USE. THE FIRST ONE FAILED AFTER 12 HOURS, THE SECOND AFTER LESS THAN 2 HOURS AND THE LEAK WAS AT THE SAME PLACE. THE TRACH WAS CHANGED FROM A 7.5 TO A 7.0 AFTER THE THIRD EVENT. THE FOURTH TUBE LEAKED IN LESS THAN 4 HOURS AND THE FIFTH LEAKED IN LESS THAN 2 HOURS.

  Patient problems: Unintended Extubation

  MAUDE report 17786198 ↗
• MalfunctionSep 20, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT REQUIRED FIVE TRACH CHANGES IN SEVEN DAYS, AND UPON INSPECTION THE TRACHEOSTOMY TUBE'S CUFF WAS LEAKING AT THE POINT WHERE THE PILOT BALLOON LINE ENTERED THE CUFF DURING USE. THE FIRST ONE FAILED AFTER 12 HOURS, THE SECOND AFTER LESS THAN 2 HOURS AND THE LEAK WAS AT THE SAME PLACE. THE TRACH WAS CHANGED FROM A 7.5 TO A 7.0 AFTER THE THIRD EVENT. THE FOURTH TUBE LEAKED IN LESS THAN 4 HOURS AND THE FIFTH LEAKED IN LESS THAN 2 HOURS.

  Patient problems: Unintended Extubation

  MAUDE report 17786188 ↗
• MalfunctionSep 20, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE 7.0MM TRACH'S CUFF WAS LEAKING WHEN AIR WAS INSERTED THRU THE PILOT BALLOON LINE DURING PRE-TESTING. NEW 7.5MM AND 7.0MM TRACH WAS PULL OUT, TESTED AND BOTH ALSO LEAKED AFTER A PERIOD OF TIME BEING INFLATED. THE MEDICAL DIRECTOR HAS PULLED ANOTHER 7.5MM WAS TESTED AND CUFF DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17784468 ↗
• MalfunctionSep 20, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE 7.0MM TRACH'S CUFF WAS LEAKING WHEN AIR WAS INSERTED THRU THE PILOT BALLOON LINE DURING PRE-TESTING. NEW 7.5MM AND 7.0MM TRACH WAS PULL OUT, TESTED AND BOTH ALSO LEAKED AFTER A PERIOD OF TIME BEING INFLATED. THE MEDICAL DIRECTOR HASPULLED ANOTHER 7.5MM WAS TESTED AND CUFF DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17784050 ↗
• MalfunctionSep 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, A NEW 7.5 AND 7 FROM THE SUPPLY ROOM WAS TESTED AND BOTH LEAKED AFTER A PERIOD OF TIME BEING INFLATED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781786 ↗
• MalfunctionJul 14, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFFS BROKE AND BLOWN WHEN USING COUGH ASSIST MACHINE. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 12167459 ↗
• MalfunctionJul 11, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AFTER INSERTION, THE DEVICE HAD CUFF LEAKAGE. THE PATIENT HAD A REPLACEMENT OF THE TUBE WITH NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148216 ↗
• MalfunctionJul 5, 2021Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY WAS INSERTED FOR A WEEK BUT THE PATIENT VOMITED TWO NIGHTS AGO. AFTER THE REPLACEMENT OF THE TUBE, THE CUFF WAS FOUND TO BE LEAKING WITH MULTIPLE HOLES ALL OVER.

  Patient problems: Unintended Extubation

  MAUDE report 12119324 ↗
• MalfunctionOct 16, 2019Crack; Crack

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CRACKED INNER CANNULA. IT WAS REPORTED THAT THESE WERE SAMPLES NOT FOR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9199352 ↗