HUDSON RCI IPN914324Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 14026704646965), received between Feb 18, 2021 and Jan 7, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED "ONE OF THE SAMPLES PROMPTLY BROKE WHEN IT WAS APPLIED TO AN INTUBATED PATIENT". REQUEST FOR ADDITIONAL INFORMATION TO CUSTOMER HAS BEEN UNSUCCESSFUL. UNKNOWN PATIENT CONDITION AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 13197283 ↗
• MalfunctionApr 5, 2021Break; Break

  MAUDE REPORT: IN THE PROCESS OF ATTEMPTING TO UNBLOCK THE ETT HOLDER DEVICE, THE RESPONDING CAREGIVER WAS UNABLE TO DO SO AS THE MECHANISM WAS BROKEN. THE TUBING WAS UNABLE TO UNBLOCK OR RELEASE.

  Patient problems: Airway Obstruction

  MAUDE report 11616330 ↗
• MalfunctionFeb 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  COMPLAINT FROM MAUDE DATABASE: WE HAD TWO INTUBATED PATIENTS WHOSE ENDOTRACHEAL TUBES WERE SECURED USING THE DEVICE. BOTH PATIENTS WERE PRONE. WHEN THE THERAPIST TURNED THE FIRST PATIENT'S HEAD, THE DEVICE BROKE. IN THE CASE OF THE SECOND PATIENT, THE HOLDERS SLID OFF THE TRACK. RESPIRATORY THERAPY REPORTED INCIDENTALLY THERE WERE MULTIPLE INSTANCES OVER THE WEEKEND OF THE TUBE HOLDERS BREAKING WHILE IN USE. MANUFACTURER RESPONSE FOR ENDOTRACHEAL TUBE HOLDER, GENTLE-LOCK (PER SITE REPORTER). WE ARE RETURNING THE REMAINING STOCK WE HAVE TO THE MANUFACTURER. WHILE WE ARE NOT CERTAIN OF THE LOT NUMBERS OF THE HOLDERS INVOLVED, ONE OF THE BOXES WE HAVE CONTAINS LOT #35063.

  Patient problems: Insufficient Information

  MAUDE report 11348081 ↗
• MalfunctionFeb 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  COMPLAINT FROM MAUDE DATABASE: WE HAD TWO INTUBATED PATIENTS WHOSE ENDOTRACHEAL TUBES WERE SECURED USING THE DEVICE. BOTH PATIENTS WERE PRONE. WHEN THE THERAPIST TURNED THE FIRST PATIENT'S HEAD, THE DEVICE BROKE. IN THE CASE OF THE SECOND PATIENT, THE HOLDERS SLID OFF THE TRACK. RESPIRATORY THERAPY REPORTED INCIDENTALLY THERE WERE MULTIPLE INSTANCES OVER THE WEEKEND OF THE TUBE HOLDERS BREAKING WHILE IN USE. MANUFACTURER RESPONSE FOR ENDOTRACHEAL TUBE HOLDER, GENTLE-LOCK (PER SITE REPORTER). WE ARE RETURNING THE REMAINING STOCK WE HAVE TO THE MANUFACTURER. WHILE WE ARE NOT CERTAIN OF THE LOT NUMBERS OF THE HOLDERS INVOLVED, ONE OF THE BOXES WE HAVE CONTAINS LOT #35063.

  Patient problems: Insufficient Information

  MAUDE report 11348070 ↗
• MalfunctionFeb 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  COMPLAINT FROM MAUDE DATABASE: WE HAD TWO INTUBATED PATIENTS WHOSE ENDOTRACHEAL TUBES WERE SECURED USING THE DEVICE. BOTH PATIENTS WERE PRONE. WHEN THE THERAPIST TURNED THE FIRST PATIENT'S HEAD, THE DEVICE BROKE. IN THE CASE OF THE SECOND PATIENT, THE HOLDERS SLID OFF THE TRACK. RESPIRATORY THERAPY REPORTED INCIDENTALLY THERE WERE MULTIPLE INSTANCES OVER THE WEEKEND OF THE TUBE HOLDERS BREAKING WHILE IN USE. MANUFACTURER RESPONSE FOR ENDOTRACHEAL TUBE HOLDER, GENTLE-LOCK (PER SITE REPORTER). WE ARE RETURNING THE REMAINING STOCK WE HAVE TO THE MANUFACTURER. WHILE WE ARE NOT CERTAIN OF THE LOT NUMBERS OF THE HOLDERS INVOLVED, ONE OF THE BOXES WE HAVE CONTAINS LOT #35063.

  Patient problems: Insufficient Information

  MAUDE report 11348066 ↗
• MalfunctionFeb 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED "THE PADS ARE NOT STICKING". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11342662 ↗