Shiley 70XLTCPRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884522027908), received between Jun 27, 2017 and Dec 9, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Defective Component” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE OF THE TRACHEOSTOMY TUBE, A PATIENT WAS FOUND TO BE BRADYCARDIC, HYPOXIC, AND HYPERCAPNIC. THE TUBE HAD A CUFF LEAK THAT WOULD NOT STAY INFLATED, AND THE OLD TUBE WAS FOUND TO HAVE A HOLE IN THE CUFF. THE TUBE WAS REPLACED.

  Patient problems: Abnormal Blood Gases; Bradycardia; Hypoxia; Unintended Extubation

  MAUDE report 23762753 ↗
• MalfunctionMay 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A DEFECTIVE TRACH TUBE WAS IDENTIFIED PRIOR TO USE DURING PRE-OPERATIVE PREPARATION. THE SPECIFIC ISSUE WAS THAT THE CUFF WOULD NOT INFLATE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038685 ↗
• MalfunctionFeb 4, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF HAD A INFLATION OR DEFLATION ISSUE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21303247 ↗
• MalfunctionJan 31, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD BREAKAGE DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18615970 ↗
• MalfunctionOct 26, 2022Defective Component; Material Split, Cut or Torn; Defective Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE UNIT WAS PRE-INFLATED AND WAITED FOR ONE MINUTE THEN FOUND THAT THE FILLED CUFF DEFLATED. THE PROCESS WAS REPEATED SEVERAL TIMES AND DETERMINED THAT THE CUFF WAS DAMAGED. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677888 ↗
• InjuryMay 11, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PRODUCT KINKED RESULTING IN MEDICAL AIRWAY EMERGENCY. THE INNER CANNULA WAS AN INTEGRAL PART OF THE 22MM ATTACHMENT FOR VENTILATOR OR SELF-INFLATING BAG. PATIENT UNDERWENT UNPLANNED EMERGENCY AIRWAY SURGERY TO CORRECT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11804064 ↗
• InjuryFeb 9, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HERNIATED WHICH CAUSED THE PATIENT TO HAVE A SERIOUS ISSUE. CUFF BULGED ON ONE SIDE AND PATIENT DECOMPENSATED, WENT INTO ASYSTOLE SLEEP, O2 DROPPED ENOUGH THAT HEARTBEAT BECAME IRREGULAR, PROBABLY THE CUFF DID NOT SEAL DURING SURGERY RESULTING IN LOSS OF SUPPLIED OXYGEN. RE CANNULATED AND USED ENDOTRACHEAL (ET) TUBE, A NEW TRACH TUBE WAS PLACED AND SECURED. THE PATIENT WAS INJURED BUT RECOVERED.

  Patient problems: Hypoxia; Unintended Extubation

  MAUDE report 11300832 ↗
• InjuryJun 27, 2017Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT, WHILE THE 980 VENTILATOR WAS BEING USED ON A PATIENT, COMPLICATIONS WITH THE PATIENT OCCURRED. THE CUSTOMER STATED THAT THE VENTILATOR PERFORMED AND ALARMED AS INTENDED WITH NO MALFUNCTION. IT IS THE CUSTOMER'S BELIEF THAT THE LARYNX MIGRATED OVER TIME, CAUSING THE SHILEY 8.0 CUFFED TRACH TO DISLODGE BETWEEN TRACHEAL RINGS AND ADIPOSE TISSUE, RESULTING IN BILATERAL PNEUMOTHORACES AND SUBCUTANEOUS EMPHYSEMA. AS A RESULT, THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND A 2ND TRACH WAS PLACED (SHILEY 7 XLT) WHICH WAS REPORTEDLY STILL NOT LONG ENOUGH. AN EMERGENCY CRICOIDECTOMY WAS PERFORMED AND AN ENDOTRACHEAL TUBE WAS PLACED WHILE THE STOMA WAS OPENED MORE AND A BOVINA TRACH WAS EVENTUALLY PLACED.

  Patient problems: Extubate

  MAUDE report 6671478 ↗