Shiley 85863Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 20884522004074), received between Dec 9, 2020 and Aug 14, 2024 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Crack” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2024Crack; Crack

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WERE SIX ENDOTRACHEAL TUBE STYLETS THAT HAD CRACKS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19988525 ↗
• MalfunctionAug 14, 2024Crack; Crack

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WERE SIX ENDOTRACHEAL TUBE STYLETS THAT HAD CRACKS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986572 ↗
• MalfunctionAug 14, 2024Crack; Crack

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WERE SIX ENDOTRACHEAL TUBE'S STYLET THAT HAD CRACKS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986553 ↗
• MalfunctionAug 14, 2024Crack; Crack

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WERE SIX ENDOTRACHEAL TUBE STYLETS THAT HAD CRACKS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986326 ↗
• MalfunctionAug 14, 2024Crack; Crack

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WERE SIX ENDOTRACHEAL TUBE STYLETS THAT HAD CRACKS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986257 ↗
• MalfunctionAug 13, 2024Crack; Crack

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WERE SIX ENDOTRACHEAL TUBE'S STYLET THAT HAD CRACKS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977601 ↗
• InjuryAug 9, 2024Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  THE INFORMATION PROVIDED WITHIN THIS RECORD IS REGARDING A PRODUCT THAT WAS NOT MANUFACTURED OR DISTRIBUTED BY MEDTRONIC. THE MANUFACTURER HAS BEEN NOTIFIED.

  Patient problems: Pain

  MAUDE report 19948746 ↗
• MalfunctionAug 6, 2024Crack; Crack

  ACCORDING TO THE REPORTER, THERE WERE TWO ENDOTRACHEAL TUBE'S STYLET THAT HAD CRACKS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19922021 ↗
• MalfunctionAug 6, 2024Crack; Crack

  ACCORDING TO THE REPORTER, THERE WERE TWO ENDOTRACHEAL TUBE'S STYLET THAT HAD CRACKS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921874 ↗
• MalfunctionFeb 29, 2024Defective Device; Defective Device

  ACCORDING TO THE REPORTER, THE STYLET WAS UNABLE TO PASS THE ENDOTRACHEAL TUBE AS THE STYLET WAS FLIMSY AND UNABLE TO MANEUVER. THE SECOND INTUBATION WAS DONE WITH NO PROBLEM.

  Patient problems: Unintended Extubation

  MAUDE report 18809452 ↗
• InjuryJan 31, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THERE WAS A REVIEW OF PRIOR X-RAYS, IT WAS NOTED THAT PRIOR RADIOLOGY REPORTS ON MULTIPLE X-RAYS SINCE BIRTH DISCUSS A POSSIBLE FOREIGN BODY IN THE MEDIASTINUM MOST RECENTLY DISCUSSED IN RADIOLOGY READ BY DOCTORS. AGAIN, AN UNUSUAL VAGUELY RADIO DENSE CATHETER WAS SEEN PROJECTING OVER THE MID-MEDIASTINUM AND AT THE RIGHT HILUM. THE PERSISTENCE OVER TIME AND STABILITY POSITION RAISES CONCERN, THIS RESIDES IN THE PATIENT RATHER THAN ON THE PATIENT. CONSIDER LATERAL CHEST RADIOGRAPHY IN FURTHER ASSESSMENT. OBTAINED A LATERAL CHEST RADIOGRAPH THAT CONFIRMED THE PRESENCE OF A TUBULAR, RADIOLUCENT STRUCTURE IN THE MID-MEDIASTINUM THAT WAS NOT AN INTENTIONALLY PLACED MEDICAL DEVICE. THE EVENT REACHED PATIENT-CAUSED SIGNIFICANT HARM OR REQUIRED MAJOR INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18614786 ↗
• MalfunctionDec 9, 2020Defective Device; Defective Device

  ACCORDING TO THE REPORTER, PRIOR TO USE, IT WAS IMPOSSIBLE TO USE THE DEVICE AS A GUIDE WIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10977650 ↗
• MalfunctionDec 9, 2020Defective Device; Defective Device

  ACCORDING TO THE REPORTER, PRIOR TO USE, IT WAS IMPOSSIBLE TO USE THE DEVICE AS A GUIDE WIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10977647 ↗