Shiley 86232 (UDI 10884521797246)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521797246), received between May 9, 2022 and May 22, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT WHEN THE PATIENT WAS INTUBATED AND A SUCTION CATHETER WAS INSERTED INTO THE LUMEN OF THE ENDOTRACHEAL TUBE, THE SUCTION TUBE COULD NOT BE INSERTED. UNDER THE ASSUMPTION THAT THE LUMEN WAS TOO NARROW, THE SUCTION TUBE WAS REINTUBATED USING A LARGER SIZE OF 2.5, AND THE TUBE HAD TO BE REMOVED, AND IT WAS DISCOVERED THAT A FOREIGN OBJECT HAD ENTERED THE LUMEN OF THE TUBE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22073186 ↗
• MalfunctionMay 1, 2024Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CONNECTOR WAS SEPARATED FROM THE TRANSPARENT TUBE BODY AND COULD NOT BE CONNECTED TIGHTLY BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221716 ↗
• InjuryApr 11, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THERE WAS AN UNPLANNED DELIVERY OF A PRE-TERM INFANT WITH NO KNOWN TERM AT THE TIME IN A MOBILE HOSPITAL UNIT. THE PATIENT HAD A CARDIOPULMONARY ARREST AND WAS RESUSCITATED BY THE ¿FIRE¿ TEAM FOR 15 MINUTES UPON ARRIVAL ON SITE. THE PATIENT WAS PLACED IN THE FACILITY TRUCK TO CONTINUE RESUSCITATION. THE RESUSCITATION CONSISTED OF WARMING UP, CONTINUING THE CARDIAC MASSAGE, AND INTUBATING TO ALLOW BREATHING AT THE BAVU AND TO DELIVER CUROSURF SURFACTANT/DRUG, WHICH WAS NOTED AS THE MOST EFFECTIVE TREATMENT IN EXTREME PREMATURE INFANTS. THE INTUBATION THROUGH THE 2.5 TUBE COULD NOT PASS THE VOCAL CORDS, SO A 2.0 TUBE WAS USED. AS THE 2.0 TUBE DID NOT HAVE A LATERAL CHANNEL FOR INTRATRACHEAL THERAPY DELIVERY (OR SCREW ¿COBB¿), IT WAS NECESSARY TO PASS THE THERAPY THROUGH THE TUBE. THE DOCTOR PUT THE SYRINGE TIP DIRECTLY INTO THE TUBE TO PUSH THE SURFACTANT FOR FASTER DELIVERY COMPARED TO DELIVERY BY PUTTING A SUCTION PROBE IN THE TUBE AND INJECTING INTO THE SUCTION PROBE. HOWEVER, BY REMOVING THE TIP CONNECTED TO THE BAVU, THE SOLID PART OF THE TIP BECAME SEVERED AND REMAINED STUCK IN THE TUBING. THIS MADE IT IMPOSSIBLE TO ADMINISTER THE CUROSURF DRUG AND VE

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 19093972 ↗
• MalfunctionMay 9, 2022Disconnection; Component Missing; Manufacturing, Packaging or Shipping Problem; Disconnection; Component Missing; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, THE PRODUCT ISSUE WAS NOTED WHEN THE ETT WAS PULLED OUT OF THE AIRWAY BOX IN THE DELIVERY ROOM FOR PREPARATION IN CASE THE PATIENT NEEDED TO BE INTUBATED. THERE WAS ONE TUBE WITHOUT THE HUB ATTACHED. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND A CONNECTOR SEPARATION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337229 ↗