Shiley 80XLTCPRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10884522027915), received between Nov 9, 2016 and Jun 4, 2026 — classified as 9 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE TRACH TUBE'S CUFF WAS FOUND "BUSTED", GRAB AND USED ANOTHER BOX. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25401217 ↗
• MalfunctionMar 13, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING USE OF THE TRACHEOSTOMY TUBE, ISSUES WITH CUFF INFLATION AND DEFLATION WERE IDENTIFIED AT THE HOSPITAL. THE PRODUCT WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24594923 ↗
• MalfunctionMar 13, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING PLACEMENT OF THE TRACHEOSTOMY TUBE, THE BALLOON WAS UNABLE TO INFLATE OR HOLD AIR AT BOTH TIMES. THE TUBE WAS REPLACED BUT THE SECOND TUBE HAD AN ISSUE AFTER INSERTION. REQUESTED FOR THE THIRD ONE FROM CENTRAL SUPPLY. BUT UPON OPENING OF THE TRACH BOX TO PASS ON THE PROVIDER NOTED THAT THE INNER STERILE PACKAGE WAS OPEN PRIOR TO RECEIVING ITEM.  THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599392 ↗
• MalfunctionMar 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PLACEMENT OF THE TRACHEOSTOMY TUBE, THE BALLOON WAS UNABLE TO INFLATE OR HOLD AIR AT BOTH TIMES. THE TUBE WAS REPLACED BUT THE SECOND TUBE HAD AN ISSUE AFTER INSERTION. REQUESTED FOR THE THIRD ONE FROM CENTRAL SUPPLY. BUT UPON OPENING OF THE TRACH BOX TO PASS ON THE PROVIDER NOTED THAT THE INNER STERILE PACKAGE WAS OPEN PRIOR TO RECEIVING ITEM.  THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599371 ↗
• MalfunctionMar 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PLACEMENT OF THE TRACHEOSTOMY TUBE, THE BALLOON WAS UNABLE TO INFLATE OR HOLD AIR AT BOTH TIMES. THE TUBE WAS REPLACED BUT THE SECOND TUBE HAD AN ISSUE AFTER INSERTION. REQUESTED FOR THE THIRD ONE FROM CENTRAL SUPPLY. BUT UPON OPENING OF THE TRACH BOX TO PASS ON THE PROVIDER NOTED THAT THE INNER STERILE PACKAGE WAS OPEN PRIOR TO RECEIVING ITEM.  THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 21599348 ↗
• MalfunctionJul 10, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE HAD FAILED LEAK TEST. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295304 ↗
• InjuryOct 25, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, PATIENT WAS INTUBATED WITH A TRACHEOSTOMY TUBE IN THE OPERATING ROOM AND WAS RETURNED TO ICU. PATIENT WAS NOT EFFECTIVELY VENTILATING, AFTER THE ASSESSMENT OF THE ICU MEDICAL STAFF, PATIENT WAS RETURNED TO THE OPERATING ROOM TO REPLACE THE TRACHEOSTOMY TUBE WITH THE SAME SIZE AND STYLE. THERE WAS "ANEURYSMAL" IN THE PART OF THE BALLOON FROM THE REMOVED TRACHEOSTOMY TUBE WHICH STRETCHED OVER THE END OF THE TUBE THAT HAD CAUSED THE BLOCKAGE.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 15668188 ↗
• MalfunctionOct 21, 2022Use of Device Problem; Obstruction of Flow; Insufficient Device Problem Information; Use of Device Problem; Obstruction of Flow; Insufficient Device Problem Information

  DUPLICATE OF PE#(B)(4) ACCORDING TO THE REPORTER, DURING USE IN THE ICU (INTENSIVE CARE UNIT), PATIENT WAS NOT EFFECTIVELY VENTILATED. PATIENT WAS RETURNED TO THE OPERATING ROOM FOR A REPLACEMENT OF THE SAME SIZE AND STYLE OF THE  TUBE. ORIGINAL TUBE BALLOON WAS FOUND WITH AND "ANEURYSMAL" THAT STRETCHED OVER THE END OF THE TUBE THAT CAUSED A BLOCKAGE.

  Patient problems: Unintended Extubation

  MAUDE report 15653970 ↗
• MalfunctionOct 3, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, AFTER DISPENSING THE STERILE TRACHEOSTOMY TUBE TO THE FIELD, THE SURGICAL TECH TESTED THE BALLOON AND NOTICED THERE WAS A HOLE IN THE CUFF. A NEW TRACHEOSTOMY TUBE WAS LOCATED AND DISPENSED IN ITS' PLACE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15530745 ↗
• InjuryMar 9, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE TRACH TUBE WAS PLACED AND ANESTHESIA VENT CIRCUIT WAS CONNECTED. THE PATIENT WAS NOT ABLE TO BE VENTILATED, AND THERE WAS NO END TIDAL CO2 AND THE PATIENT EXPERIENCED TRANSIENT 02 DESATURATION. TRACH TUBE WAS INSPECTED AND CONFIRMED TO BE IN CORRECT POSITION IN THE TRACHEA WITH BALLOON INFLATED. ATTEMPTED TO VENTILATE THE PATIENT THROUGH THIS TUBE BUT CONTINUED TO BE UNSUCCESSFUL. THE TRACH TUBE WAS QUICKLY REMOVED AND A REINFORCED ETT WAS IMMEDIATELY PLACED INTO THE TRACHEAL STOMA SUCCESSFULLY LEADING TO THE ABILITY TO VENTILATE THE PATIENT. THE PATIENT'S 02 SATURATION QUICKLY IMPROVED TO BASELINE. AT THIS TIME, A NEW AND DIFFERENT TRACH TUBE WAS SUCCESSFULLY PLACED AND CONNECTED TO THE VENT CIRCUIT WITHOUT ISSUE. THE DEVICE WAS INSPECTED AND THE INNER CANNULA OF THIS TUBE APPEARED TO BE SEVERELY DAMAGED/KINKED THAT LED TO INABILITY TO VENTILATE THE PATIENT.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 13711579 ↗
• InjuryOct 22, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE WAS UNABLE TO BE PLACED BECAUSE IT KEPT BENDING AND CAUSED THE TRACHEA TO COLLAPSE. ON RE-ATTEMPTING TO PLACE THE DEVICE, IT STARTED TO BEND AGAIN AND CAUSE THE TRACHEA TO COLLAPSE. THE PATIENT'S VITAL SIGNS DROPPED. COMPRESSIONS AND PLACEMENT OF A ENDOTRACHEAL TUBE WERE PERFORMED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR AN OPEN TRACHEOSTOMY. HYBRID METHOD WAS USED WHERE A CUT INTO THE ANATOMY BEFORE PERFORMING PERCUTANEOUS INSERTION. PATIENT HAD EXCESSIVE SKIN BREAKDOWN ON THE NECK AS A RESULT OF THE DIFFICULTY.

  Patient problems: Skin Tears; Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 12682961 ↗
• MalfunctionSep 16, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD A BALLOON PRONE TO RUPTURE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12481931 ↗
• MalfunctionSep 16, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD A BALLOON PRONE TO RUPTURE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12481487 ↗
• MalfunctionJul 27, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BALLOON FAULTED SLID DOWN TUBE AND BLOCKED OFF TRACHEOSTOMY. THE PATIENT STATUS WAS ASKED BUT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12231646 ↗
• InjurySep 30, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE FLANGE ON THE TRACHEOSTOMY SNAPPED OFF (BROKE OFF). THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 10609882 ↗
• MalfunctionSep 30, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE FLANGE ON THE TRACHEOSTOMY SNAPPED OFF (BROKE OFF). THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10609858 ↗
• InjuryOct 16, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE UNIT'S CUFF WOULD NOT INFLATE. THE PRODUCT AND CUFF FAILURE LED TO RESPIRATORY COMPROMISE, INABILITY TO EFFECTIVELY OXYGENATE - HAEMODYNAMIC INSTABILITY FOLLOWED AND PATIENT NOW ON PRESSORS. THE PATIENT HAD TO BE TAKEN BACK TO THEATRE TO REINSERT AGAIN A NEW DEVICE TO MINIMIZE LEAKS THE PATIENT WAS NOT ABLE TO BE TURNED OR SUCTIONED AND HUGE RISK OF ARWAY LOSS WITH ENDOTRACHEAL INTUBATION TO TRY OR STABILIZE PATIENT DURING THE NIGHT.

  Patient problems: Extubate

  MAUDE report 7969999 ↗
• InjurySep 6, 2018Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE DEVELOPED A LEAK IN THE CUFF. IT WAS ALSO REPORTED THAT THE CUFF WAS THEN REPLACED. CUSTOMER INDICATED THAT THERE WAS HIGHER AMOUNT OF SECRETIONS THAN THE USUAL FOR THE PATIENT.

  Patient problems: Extubate

  MAUDE report 7850661 ↗
• InjuryDec 4, 2017Deflation Problem; Deflation Problem

  MANUFACTURER RECEIVED A COMMUNICATION REGARDING A CUFF THAT WOULD NOT INFLATE. THE CUSTOMER REPORTED THAT THIS OCCURRED WHILE THE DOCTOR WAS TRYING TO INSTALL A NEW TUBE ON THE PATIENT BUT IT WAS STATED THAT NO HARM OCCURRED. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED AS THE REPRESENTATIVE INFORMED THAT RECANNULATION WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 7081238 ↗
• InjuryOct 16, 2017Occlusion Within Device; Occlusion Within Device

  MEDTRONIC RECEIVED A COMMUNICATION REGARDING A BUBBLE PREVENTING AIRFLOW. CUSTOMER REPORTED THAT THE PATIENT HAD RESPIRATORY DISTRESS AFTER THE TRACHEOSTOMY TUBE WAS CHANGED. ACCORDING TO THE REPORTER, A BUBBLE WAS NOTED ON THE CUFF OF THE TUBE COVERING THE END PREVENTING AIR FLOW THROUGH THE TUBE. THE CUSTOMER INDICATED A TUBE HAD TO BE PLACED AGAIN.

  Patient problems: Extubate

  MAUDE report 6952329 ↗
• InjuryNov 9, 2016Physical Resistance

  SHILEY TRACHE TUBE # 8.0 MM BULB NON FUNCTIONING. A SIZE 8 SHILEY XLTP TRACHEOSTOMY WAS PLACED INTO THE TRACHEA UNDER DIRECT VISUALIZATION AND THE BALLOON WAS INFLATED. WE CAREFULLY COORDINATED WITH OUR ANESTHESIA COLLEAGUE DURING THIS TIME AND THE VENTILATOR CIRCUIT WAS MOVED TO THE TRACH. INITIALLY, WE HAD GOOD END TIDAL CO2 AND TIDAL VOLUMES. HOWEVER, LESS THAN A MINUTE LATER, NO END TIDAL CO2 WAS NOTED AND THE PT BEGAN TO DESATURATE. WE ARE STILL ABLE TO VISUALIZE THE TRACHEOSTOMY APPLIANCE IN THE TRACHEA. ANESTHESIA NOTED IT WAS DIFFICULT TO BAG THE PT. A SUCTION CATHETER WAS PLACED THROUGH THE TRACH AND RESISTANCE WAS MET. AT THIS TIME, WE ELECTED TO REMOVE THE TRACH AND REEVALUATE THE TRACHEA. THE BALLOON WAS DEFLATED AND THE APPLIANCE REMOVED.

  Patient problems: Extubate

  MAUDE report 6099230 ↗