HUDSON RCI IPN044854Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026704397594), received between Nov 15, 2024 and Nov 15, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Crack” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K961977); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Crack; Crack

  IT WAS REPORTED THAT: "(B)(6) 2024, AFTER THE PATIENT'S TRACHEAL INTUBATION WENT SMOOTHLY, THE OXYGEN SATURATION SUDDENLY DROPPED TO 86% HALFWAY THROUGH THE SURGERY, OXYGEN CONCENTRATION, OXYGEN FLOW, TIDAL VOLUME WERE IMMEDIATELY ADJUSTED, AND OXYGEN SATURATION WAS RESTORED TO 100% AFTER SPUTUM SUCTIONING. THE REASON FOR THIS WAS FOUND TO BE A CRACK AT THE INTERFACE OF THE DOUBLE-LUMEN TUBE AFTER THE SURGERY WAS COMPLETED." THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE WITH NO HARM OR CONSEQUENCE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 20694774 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961977. One submission often covers many models, so check the product and lot details in each record.

• Z-2367-2015 · Jun 1, 2015 · Terminated
  HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bron
• Z-0125-2007 · Sep 27, 2006 · Terminated
  Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37 Fr, 26 mm tracheal cuff, 19 mm bronchial cuff; a Rx, sterile, single use endobronchial tube with modified tip for left bro