Shiley 3.5 NEORecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 30884522026660), received between Apr 23, 2018 and May 7, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K945513); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE DEVICE HAD OBSTRUCTION NEAR THE TIP OF THE TUBE. WHEN USING THE DEVICE, A SUCTION CATHETER (10FR) WAS INSERTED, BUT IT DID NOT ENTER. THEY USED ANOTHER DEVICE BUT THE SAME SUCTION CATHETER WAS NOT INCLUDED, IT DISAPPEARED WHEN REPLACED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 11791291 ↗
• MalfunctionSep 4, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, FIVE DAYS AFTER THE START OF USE, THE HOLE ON THE DEVICE WHICH FIXED THE TUBE OF THE NECK FLANGED GOT DAMAGED AND UNABLE TO BE FIXED. COTTON TAPE WAS USED. THE EVENT OCCURRED THREE TIMES IN A ROW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10492967 ↗
• MalfunctionAug 21, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, FIVE DAYS AFTER THE START OF USED, THE HOLE ON THE DEVICE WHICH FIXED THE TUBE OF THE NECK FLANGED GOT DAMAGED AND UNABLE TO FIX, COTTON TAPE WAS USED. THE EVENT OCCURRED THREE TIMES IN A ROW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437129 ↗
• MalfunctionAug 17, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, FIVE DAYS AFTER THE START OF USED, THE HOLE ON THE DEVICE WHICH FIXED THE TUBE OF THE NECK FLANGED GOT DAMAGED AND UNABLE TO FIX, COTTON TAPE WAS USED. THE EVENT OCCURRED THREE TIMES IN A ROW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10414531 ↗
• MalfunctionAug 17, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, FIVE DAYS AFTER THE START OF USED, THE HOLE ON THE DEVICE WHICH FIXED THE TUBE OF THE NECK FLANGED GOT DAMAGED AND UNABLE TO FIX, COTTON TAPE WAS USED. THE EVENT OCCURRED THREE TIMES IN A ROW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10414493 ↗
• MalfunctionAug 17, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, FIVE DAYS AFTER THE START OF USED, THE HOLE ON THE DEVICE WHICH FIXED THE TUBE OF THE NECK FLANGED GOT DAMAGED AND UNABLE TO FIX, COTTON TAPE WAS USED. THE EVENT OCCURRED THREE TIMES IN A ROW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10414416 ↗
• MalfunctionDec 12, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE OBTURATOR WAS DIFFICULT TO INSERT, IT JAMS DURING INSERTION AND REMOVAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9455797 ↗
• MalfunctionApr 23, 2018Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, DURING INSPECTION PRIOR TO USE ON A PATIENT, THE TUBE WAS FOUND DISCOLORED. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7452179 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K945513. One submission often covers many models, so check the product and lot details in each record.

• Z-0997-2009 · Jan 14, 2009 · Terminated
  Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. The pr