Mallinckrodt 86113Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 40884522000131), received between May 1, 2017 and Jul 13, 2020 — classified as 1 death, 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K871204); 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 18, 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.

• InjuryJul 13, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE INTUBATED PATIENT UNDER THE EFFECTS OF HIGH SEDATION, HAD A SEVERAL OCCASIONS WITH PILOT BALLOON LEAKAGE IN THE ENDOTRACHEAL TUBE DESPITE THE INSUFFLATED PNEUMATIC CAPPER, REQUIRING PRESSURE CALIBRATION REPEATED AND TUBE REARRANGEMENT TO COMPENSATE FOR EXISTING LEAKAGE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Extubate; No Information

  MAUDE report 10263579 ↗
• MalfunctionJul 11, 2019Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE DEVICE CUFF WAS TORN UP WHEN TRIED TO INFLATE WITH A SYRINGE. IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8780538 ↗
• InjuryJun 28, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, DURING MEDICAL ROUND, PULMONARY VOLUME LEAK WAS IDENTIFIED. PATIENT'S POSTURE WAS CHANGED TO SUPINE AND CHANGED THE ENDOTRACHEAL TUBE.

  Patient problems: Extubate

  MAUDE report 8744192 ↗
• InjuryJun 28, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, DURING MEDICAL ROUND, PULMONARY VOLUME LEAK WAS IDENTIFIED. PATIENT'S POSTURE WAS CHANGED TO SUPINE AND CHANGED THE ENDOTRACHEAL TUBE.

  Patient problems: Extubate

  MAUDE report 8744159 ↗
• DeathSep 6, 2018Material Rupture; Material Rupture

  ACCORDING TO THE REPORTER, THE DEVICE'S BOX WAS CHECKED AND THERE WAS A PHYSICAL DEFECT BEFORE OPENING. IT WAS INDICATED THAT THE CUFF BURST WHILE IN USE IN THE PATIENT. A CUSTOMER REPORTED THAT THE AROUND 3 MINUTES AFTER USING, THEY NOTICED THAT THE PATIENT WAS NOT RESPONDING AND THAT THE CUFF DID NOT INFLATE. IT WAS ALSO REPORTED THAT THEY TRIED TO INFLATE THE CUFF, BUT IT WOULD NOT HOLD AIR. A CUSTOMER REPORTED THAT THE PATIENT WAS REINTUBATED WITH THE SAME SIZE TRACHEOSTOMY AND NEITHER INTUBATION WAS EXTREMELY DIFFICULT AND THE PATIENT EXPIRED A SHORT TIME LATER.

  Patient problems: Death; Extubate; No Consequences Or Impact To Patient

  MAUDE report 7850693 ↗
• MalfunctionDec 15, 2017Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER DURING INSPECTION PRIOR TO USE ON A PATIENT, THE CUFF DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7121998 ↗
• MalfunctionDec 13, 2017Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER: PRIOR TO USE ON A PATIENT, AIR LEAKED FROM THE CUFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7114972 ↗
• MalfunctionJun 27, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, A PIECE OF HAIR WAS FOUND CONTAINED IN THE PACKAGE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6671562 ↗
• MalfunctionMay 1, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE TUBE WAS OPENED, IT IS OBSERVED THAT THE BALLOON DID NOT INFLATE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6534743 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K871204. One submission often covers many models, so check the product and lot details in each record.

• Z-1318-2023 · Feb 10, 2023 · Open, Classified
  COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal in