Shiley 110870Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 40884521068217), received between Apr 22, 2019 and Nov 13, 2023 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (10 reports).

2 other recalls cover devices cleared under the same FDA submission (K082520); 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF HAD ACCUMULATED WATER DURING USE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 18122207 ↗
• MalfunctionSep 20, 2021Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  ACCORDING TO THE REPORTER, WHEN AN ATTEMPT WAS MADE TO REMOVE THE CUFF AIR TO REPLACE IT WITH A TRACHEOSTOMY TUBE, ABOUT 2CC OF WATER WAS DRAWN INTO THE SYRINGE. SYMPTOM WAS CONFIRMED WHEN TRANSITIONING TO TRACHEOTOMY TUBE RATHER THAN REINTUBATION.

  Patient problems: Unintended Extubation

  MAUDE report 12497084 ↗
• InjurySep 3, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8957627 ↗
• InjurySep 3, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8957625 ↗
• InjurySep 3, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8957619 ↗
• InjurySep 3, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8957616 ↗
• InjurySep 3, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8957286 ↗
• InjurySep 3, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8957285 ↗
• InjurySep 3, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8957283 ↗
• InjurySep 3, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8957279 ↗
• InjuryAug 13, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE CUSTOMER INDICATED THAT THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8887074 ↗
• InjuryJun 4, 2019Leak/Splash; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8666974 ↗
• InjuryJun 4, 2019Leak/Splash; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8666971 ↗
• InjuryJun 4, 2019Leak/Splash; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE HAD WATER DROPLETS GENERATING IN THE PILOT BALLOON AFTER 24 HOURS OF BEING USED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8666963 ↗
• InjuryApr 29, 2019Partial Blockage; Partial Blockage

  ACCORDING TO THE REPORTER, THE UNIT WATER DROPLETS ACCUMULATED THE PILOT BALLOON AND DEFLATION WAS DIFFICULT TO PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 8561805 ↗
• MalfunctionApr 23, 2019Partial Blockage; Use of Device Problem; Partial Blockage; Use of Device Problem

  ACCORDING TO THE REPORTER, WATER DROPLETS ACCUMULATED IN THE PILOT BALLOON PART AND DEFLATION WAS DIFFICULT. THE AUTOMATIC CUFF PRESSURE GAUGE WAS NOT USED AND REGULAR CUFF PRESSURE MANAGEMENT HAD BEEN PERFORMED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8542373 ↗
• InjuryApr 22, 2019Leak/Splash; Obstruction of Flow; Leak/Splash; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE DEVICE CUFF HAD INFLATION/DEFLATION ISSUE. IT WAS REPORTED THAT TUBE OCCLUDED AND THE PATIENT REQUIRED EXTUBATION, RE -INTUBATION AND BRONCHOSCOPY.

  Patient problems: Extubate

  MAUDE report 8537193 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082520. One submission often covers many models, so check the product and lot details in each record.

• Z-1625-2016 · Apr 4, 2016 · Terminated
  Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
• Z-1626-2016 · Apr 4, 2016 · Terminated
  Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..