Shiley 6IC75Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10884521511958), received between Nov 20, 2018 and Apr 13, 2026 — classified as 1 death, 6 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Crack” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K142296); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULA EXPERIENCED DAMAGE TO THE BODY AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866908 ↗
• MalfunctionAug 28, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE TRACHEOSTOMY INNER CANNULA PORT WAS CLOSED. THE ISSUE WAS IDENTIFIED AT THE HOSPITAL AND WAS NOT ASSOCIATED WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912569 ↗
• MalfunctionAug 1, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULA OF THE WOULD NOT INSERT INTO THE TRACHEOSTOMY TUBE PROPERLY AND EXCESSIVE FORCE WAS REQUIRED TO INSERT THE INNER CANNULA INTO DURING PRE-OPERATIVE PREPARATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22692937 ↗
• MalfunctionMay 12, 2025Crack; Crack

  IT WAS REPORTED THAT THE TRACHEOSTOMY INNER CANNULA WAS CRACKED, MARKING THE SECOND OCCURRENCE OF SUCH AN ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000107 ↗
• MalfunctionMay 12, 2025Crack; Crack

  IT WAS REPORTED THAT THE TRACHEOSTOMY INNER CANNULA WAS CRACKED, MARKING THE SECOND OCCURRENCE OF SUCH AN ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000074 ↗
• MalfunctionJan 6, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT, PRIOR TO USAGE, THE HEALTH CARE PROFESSIONAL NOTICED "FLASH" LEFT OVER THE END OF THE TRACHEOSTOMY TUBE'S CANNULA. IT APPEARED TO BE MELTED, MAKING IT UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081465 ↗
• InjuryDec 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING USE, THE TRACHEOSTOMY TUBE'S INNER CANNULA WAS FOUND BROKE OFF INSIDE THE PATIENT, AS SHOWN IN THE ATTACHED IMAGE, 1/3 OF THE PIECE WAS ABLE TO REMOVED FROM THE PATIENT AND PUT ON A VENTILATOR. THE TUBE WAS REPLACED AFTER THE INCIDENT. INNER CANNULAS WAS BEING REPLACED EVERY 24 HOURS.

  Patient problems: Foreign Body In Patient; Unintended Extubation

  MAUDE report 21035135 ↗
• MalfunctionAug 9, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE BALLOONS OF THE TWO TRACHEOSTOMY TUBES HAD A SLOW-LEAKING HOLE. THERE WAS NO PATIENT IN VOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19946734 ↗
• MalfunctionAug 9, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE BALLOONS OF THE TWO TRACHEOSTOMY TUBES HAD A SLOW-LEAKING HOLE. THERE WAS NO PATIENT IN VOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19946720 ↗
• MalfunctionJun 19, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INNER CANNULA WAS VERY STIFF GOING IN AND OUT OF THE TRACH TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571106 ↗
• MalfunctionJun 19, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INNER CANNULA WAS VERY STIFF GOING IN AND OUT OF THE TRACH TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570516 ↗
• MalfunctionJan 11, 2024Crack; Crack

  ACCORDING TO THE REPORTER, THE THREE TRACHEOSTOMY TUBE'S INNER CANNULA HAD CRACKS BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499730 ↗
• MalfunctionJan 11, 2024Crack; Crack

  ACCORDING TO THE REPORTER, THE THREE TRACHEOSTOMY TUBE'S INNER CANNULA HAD CRACKS BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499710 ↗
• MalfunctionJan 11, 2024Crack; Crack

  ACCORDING TO THE REPORTER, THE THREE TRACHEOSTOMY TUBE'S INNER CANNULA HAD CRACKS BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499686 ↗
• MalfunctionSep 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACH'S TUBE WAS SPLIT BROKEN DURING USE, BASED ON PHOTO'S ATTACHED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 17724373 ↗
• MalfunctionAug 8, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY'S INNER CANNULA WAS TOO NARROW, TOO LONG, EASY TO PLUG, MORE RESISTANCE IN BREATHE OR SUCTION THROUGH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481399 ↗
• InjuryApr 7, 2023Crack; Component Missing; Crack; Component Missing

  ACCORDING TO THE REPORTER, THE DEVICE INNER CANNULA HAD A CRACK THAT CAUSED BLEEDING IN THE PATIENT'S AIRWAY. TUBE WAS REPLACED. IT WAS FOUND OUT THAT THE CUFF FROM THE REMOVED DEVICE WAS MISSING.

  Patient problems: Bronchial Hemorrhage; Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 16700969 ↗
• MalfunctionApr 5, 2023Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICES CUFF BROKE AND THE INNER CANNULA CRACKED DURING PROCEDURE. THE PATIENTS AIRWAY BLED.

  Patient problems: Foreign Body In Patient; Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 16682210 ↗
• MalfunctionJan 25, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE INNER CANNULA WAS NOT FITTING IN THE PATIENT'S TRACH, AND NEED TO FORCE THE INNER CANNULA IN. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241236 ↗
• MalfunctionNov 2, 2022Crack; Installation-Related Problem; Crack; Installation-Related Problem

  ACCORDING TO THE REPORTER, DURING USE, THE INNER CANNULA CRACKED AFTER HOURS OF BEING IN PLACE. IT WAS ALSO REPORTED THAT THE TRACHEOSTOMY DID NOT FIT CORRECTLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714192 ↗
• MalfunctionSep 6, 2022Crack; Defective Component; Crack; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT'S REUSABLE INNER CANNULA THAT WAS IN THE ROOM WAS FOUND TO BE SLIGHTLY BENT AND CRACKED. INNER CANNULA WAS BAGGED UP AND GIVEN TO NURSE MANAGER. ENT APN NOTIFIED AS WELL AS THE RT. A NEW INNER CANNULA WAS OBTAINED AND THE BROKEN ONE WAS REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366540 ↗
• MalfunctionSep 6, 2022Crack; Defective Component; Crack; Defective Component

  ACCORDING TO THE REPORTER, DURING ROUTINE INNER CANNULA CHANGE, THE INNER CANNULA WAS REMOVED WITH SLIGHT RESISTANCE. ONCE OUT, THE NURSE NOTICED THE CREASE IN THE INNER CANNULA AND ASSOCIATED THAT WITH THE RESISTANCE OF REMOVAL. THE REMOVED INNER CANNULA WAS NOTED TO HAVE A BEND IN THE CANNULA AND MINOR CRACKING ON SIDES. A NEW INNER CANNULA WAS PLACED AT BEDSIDE FOR NEXT CHANGE.

  Patient problems: Unintended Extubation

  MAUDE report 15365874 ↗
• InjuryJul 20, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE INNER COMPONENT OF THE DEVICE WAS COATED WITH ¿RUBBER CEMENT LIKE GOOP". THE PATIENT COULD NOT BREATHE RIGHT IN THREE HOURS OR LESS. EXCESSIVE FORCE WAS REQUIRED TO GET THE INNER PART OF THE DEVICE PULLED OUT.

  Patient problems: Dyspnea; Unintended Extubation

  MAUDE report 15070671 ↗
• MalfunctionApr 22, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT WAS RUSHED TO THE HOSPITAL AND LATER RELEASED BECAUSE THE INNER CANNULA DID NOT FIT THE TRACH. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 14189520 ↗
• MalfunctionOct 19, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE INNER CANNULA OF THE DEVICE WAS GETTING STUCK INSIDE THE PATIENT'S TRACHEOSTOMY. IT WAS STATED THAT THE DEVICE WAS DIFFICULT TO ACTUALLY GRASP, PINCH AND PULL ON THE INNER CANNULA AND SOME HAD TO USE HEMOSTATS TO REPLACE THE INNER CANNULA. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662058 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142296. One submission often covers many models, so check the product and lot details in each record.

• Z-1357-2023 · Mar 24, 2023 · Open, Classified
  Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CU