HUDSON RCI IPN914325Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14026704646972), received between Apr 29, 2021 and Feb 19, 2025 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT "THIS PRODUCT IS NOT SECURING ENDOTRACHEAL TUBES EFFECTIVE, AND RECENTLY A PATIENT COUGHED AND SELF-EXTUBATED THEMSELVES. TWO ADDITIONAL PATIENTS WERE FOUND TO HAVE THEIR ENDOTRACHEAL TUBES 4-6CM HIGHER THAN ORIGINALLY SECURED. RRT VERIFIED THAT THE TUBE HOLDERS WERE BEING USED CORRECTLY; HOWEVER, THE TUBES STILL MIGRATED . AFTER CHANGING THE SECUREMENT DEVICE, IT WAS NOTED IT WAS NO LONGER STICKING ON THE CHEEK PADS NOR THE STRAPS AROUND THE TUBE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21413758 ↗
• MalfunctionFeb 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT "THIS PRODUCT IS NOT SECURING ENDOTRACHEAL TUBES EFFECTIVE, AND RECENTLY A PATIENT COUGHED AND SELF-EXTUBATED THEMSELVES. TWO ADDITIONAL PATIENTS WERE FOUND TO HAVE THEIR ENDOTRACHEAL TUBES 4-6CM HIGHER THAN ORIGINALLY SECURED. RRT VERIFIED THAT THE TUBE HOLDERS WERE BEING USED CORRECTLY; HOWEVER, THE TUBES STILL MIGRATED . AFTER CHANGING THE SECUREMENT DEVICE, IT WAS NOTED IT WAS NO LONGER STICKING ON THE CHEEK PADS NOR THE STRAPS AROUND THE TUBE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21413728 ↗
• MalfunctionFeb 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT "THIS PRODUCT IS NOT SECURING ENDOTRACHEAL TUBES EFFECTIVE, AND RECENTLY A PATIENT COUGHED AND SELF-EXTUBATED THEMSELVES. TWO ADDITIONAL PATIENTS WERE FOUND TO HAVE THEIR ENDOTRACHEAL TUBES 4-6CM HIGHER THAN ORIGINALLY SECURED. RRT VERIFIED THAT THE TUBE HOLDERS WERE BEING USED CORRECTLY; HOWEVER, THE TUBES STILL MIGRATED . AFTER CHANGING THE SECUREMENT DEVICE, IT WAS NOTED IT WAS NO LONGER STICKING ON THE CHEEK PADS NOR THE STRAPS AROUND THE TUBE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21413680 ↗
• DeathMay 11, 2022Migration; Migration

  IT WAS REPORTED VIA THE MEDWATCH FORM THAT THE ENDOTRACHEAL TUBE (ETT) HOLDER WAS IN PLACE, RT FOUND THE ETT TUBE MAY HAVE BEEN ALLOWED TO MIGRATE/DISLODGE. THERE ARE REPORTS THAT THIS TUBE HOLDER DOES NOT WORK AS DESIGNED TO SECURE THE ETT TUBES AND PREVENT FROM DISLODGING." THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION IS REPORTED AS "DECEASED": (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS CONFIRMED THAT THE TELEFLEX ET HOLDER HAD BEEN IN PLACE ON (B)(6) 2022 PRIOR TO THE PASSING OF THE PATIENT AND WAS LEFT IN PLACE BY THE RT'S PRESENT POST CODE, AND DID NOT DIRECTLY CONTRIBUTE TO THE PATIENT'S DEATH.

  Patient problems: Insufficient Information

  MAUDE report 14356479 ↗
• MalfunctionApr 29, 2021Break; Break

  IT WAS REPORTED "WE HAD A PATIENT IN SICU BITE THROUGH THE BLOCK ANDHIS ETT REQUIRING EMERGENT REINTUBATION". IT WAS REPORTED THAT "PATIENTS CURRENT CONDITION IS EXTUBATED AND DISCHARGED FROM FACILITY". NEW DEVICE WAS USED WITH NO REPORT OF PATIENT INJURY OR HARM.

  Patient problems: Unintended Extubation

  MAUDE report 11747021 ↗