Shiley 3.5 PEDRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 30884522026707), received between Sep 18, 2017 and Jul 7, 2023 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA WAS DIFFICULT TO CONNECT WITH THE 15 MM CONNECTOR THAN USUAL DURING USE. THE CONNECTION WAS POSSIBLE, BUT WAS SHALLOW AND IN A STATE WHERE SEEMED TO COME OFF IMMEDIATELY. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17278334 ↗
• 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 11791369 ↗
• InjuryApr 9, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S NECK FLANGE HAD BEEN CUT. IT WAS STATED THAT A STRING WAS USED TO FIX THE ISSUE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 9943830 ↗
• MalfunctionMar 4, 2020Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, DURING USE, UPON USAGE ON THE 7TH DAY, DISCOLORATION ON THE TUBE END HAPPENED. TUBE WAS STERILIZED AND RINSED WITH ALKALINE WATER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9789144 ↗
• InjuryOct 9, 2019Disconnection; Disconnection

  ACCORDING TO THE REPORTER, DURING USE, THE FLANGE/NECK HOLDER CONNECTION PART BROKE WITHIN ONE MONTH AFTER THE START OF USING THE PRODUCT. RECANNULATION OF A REPLACEMENT TUBE WAS PERFORMED.

  Patient problems: Extubate

  MAUDE report 9171712 ↗
• MalfunctionJun 19, 2019Crack; Crack

  ACCORDING TO THE REPORTER, WHEN THE CANNULA BAND WAS REPLACED A CRACK WAS FOUND ON THE LEFT FIXING STRAP SITE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714767 ↗
• MalfunctionApr 4, 2018Break; Break

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICE¿S FLANGE WAS BROKEN. THE CUSTOMER INDICATED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7397818 ↗
• InjurySep 19, 2017Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED A REPORT THAT AFTER PATIENT INTUBATION THE CANNULA SIZE 3.5 WAS "OUT OF SITE" AND WAS "CAUSING A LACK OF THORACIC EXPANSION". THE PATIENT WAS RECANNULATED WITH A SIZE 4 CANNULA.

  Patient problems: Extubate

  MAUDE report 6876392 ↗
• InjurySep 18, 2017Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS ACCIDENTALLY "EXCRETED" BUT RESPIRATORY EFFORTS WERE PRESENTED AND CPAP WAS PLACED AS MEDICAL INTERVENTION.

  Patient problems: Extubate

  MAUDE report 6874168 ↗

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