Mallinckrodt 86111Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 40884522000117), received between Jun 7, 2017 and Jul 15, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USAGE, BOTH ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742562 ↗
• MalfunctionJul 11, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725635 ↗
• MalfunctionJul 11, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USAGE, BOTH OF THE ENDOTRACHEAL TUBES' CUFFS HAD INFLATION OR DEFLATION ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725617 ↗
• MalfunctionAug 7, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS TESTED PRIOR TO USE BY INJECTING AIR. IT WAS NOTED THAT THERE WAS INCREASED RESISTANCE DURING BOTH INFLATION AND DEFLATION. THE PATIENT WAS SUCCESSFULLY INTUBATED WITH ANOTHER DEVICE OF UNDETERMINED LOT.

  Patient problems: No Patient Involvement

  MAUDE report 8872473 ↗
• InjuryMay 16, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, DURING A SURGERY, THE ANESTHESIOLOGIST WAS HAVING MORE AND MORE TROUBLE VENTILATING THE PATIENT AND DECIDED TO RE-INTUBATE THE PATIENT. AFTER REMOVING THE ORIGINAL TUBE AND CHECKING THE BALLOON ON IT, IT WAS FOUND TO HAVE A LARGE BULGE OUT THE SIDE, CAUSING COMPRESSION ON OTHER PARTS OF THE AIRWAY.

  Patient problems: Extubate

  MAUDE report 8618477 ↗
• MalfunctionAug 7, 2018Component Missing; Appropriate Device Problem Term/Code Not Available; Component Missing

  ACCORDING TO THE REPORTER, 8 BOXES WERE RECEIVED EMPTY. CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7757156 ↗
• MalfunctionNov 8, 2017Air Leak; Air Leak

  MEDTRONIC RECEIVED A REPORT THAT ACCORDING TO THE REPORTER THE PILOT BALLOON VALVE BROKE DURING CUFF TESTING. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7010236 ↗
• MalfunctionOct 16, 2017Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A COMMUNICATION THAT DURING PREPARATION PRIOR TO USE, THE TUBE TIP WAS FOUND DEFORMED. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6952197 ↗
• MalfunctionOct 9, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION REGARDING PILOT BALLOON / PILOT VALVE. ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6932328 ↗
• MalfunctionJul 19, 2017Contamination; Contamination

  MEDTRONIC RECEIVED A REPORT DURING INSPECTION, BLACK FOREIGN MATERIAL WAS FOUND INSIDE THE CUFF. CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6726381 ↗
• MalfunctionJun 9, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THE CUFF ON THE TRACHEOSTOMY TUBE WOULD NOT INFLATE. CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6632440 ↗
• MalfunctionJun 7, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THE CUFF ON THE ENDOTRACHEAL TUBE EXPERIENCED INFLATION/DEFLATION ISSUES. CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6620447 ↗

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