HUDSON RCI IPN043837Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04026704388769), received between Nov 30, 2021 and Aug 23, 2022 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 11, 2022Class IIOpen, Classified

   Reports received of torn corrugated breathing tubes.

   Z-1127-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  COMPLAINT REPORTED THAT: I WAS INFORMED BY THE PHYSICIAN THAT OUR FLEX TUBE (20011) SPLIT, WHILE IN USE WITH A PATIENT IN SURGERY. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274508 ↗
• MalfunctionMay 7, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE MATERIAL OF THE DEVICES IS TEARING OPEN. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION WAS REQUESTED TO THE CUSTOMER HAS BEEN UNSUCCESSFUL. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 14317865 ↗
• MalfunctionMar 31, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "DEVICE IS RUPTURED DURING USE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE". NEW DEVICE USED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13959315 ↗
• MalfunctionMar 11, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE MATERIAL [TEARS]". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13737684 ↗
• MalfunctionMar 11, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE MATERIAL [TEARS]". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13737614 ↗
• MalfunctionMar 11, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE MATERIAL [TEARS]". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13737405 ↗
• MalfunctionMar 11, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE MATERIAL [TEARS]". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13737324 ↗
• MalfunctionMar 4, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "TORN PRODUCT FOUND WHILE CONNECTING BREATHING CIRCUIT TO AIR WAY". NO ADDITIONAL INFORMATION PROVIDED AT TIME OF REPORT. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 13667441 ↗
• MalfunctionFeb 21, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "DURING A FACELIFT PROCEDURE IT WAS NOTICED THAT THE END OF THE FLEX TUBE HAD BECOME TORN. DUE TO THIS, IT WAS NECESSARY TO MANUALLY BAG THE PATIENT AND SWITCH THE FLEX TUBE WITH A DIFFERENT LOT NUMBER. THE PATIENT DESATURATED BRIEFLY DURING THE PROCEDURE". ADDITIONAL INFORMATION PROVIDED STATED THAT PATIENT DESATURATED "5-6 POINTS", NO BASELINE INFORMATION PROVIDED. NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION IS REPORTED TO BE "100%".

  Patient problems: Low Oxygen Saturation

  MAUDE report 13569535 ↗
• MalfunctionFeb 21, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "FLEX TUBE HAD BECOME TORN". ADDITIONAL INFORMATION STATES THAT "ISSUE HAS HAPPENED WITH MULTIPLE DIFFERENT SURGEONS AND ANESTHESIA PROVIDERS ON SEVERAL DIFFERENT PATIENTS WITH THE SAME DEFECT DURING [ELECTIVE] SURGERY". ADDITIONAL INFORMATION STATED THAT "ANESTHESIA PROVIDER NOTICED A DROP IN THE O2 SATURATION" BUT NO OTHER SPECIFIC PATIENT INFORMATION PROVIDED AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 13569517 ↗
• MalfunctionFeb 3, 2022Break; Break

  IT WAS REPORTED THAT "THE MATERIAL OF SEVERAL DEVICES OF THIS LOT IS BREAKING. DEFECT WAS NOTED PRIOR TO USE". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446668 ↗
• MalfunctionDec 3, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "CORRUGATED EXTENSION USED TO CONNECT ANESTHESIA CIRCUIT TO ENDOTRACHEAL TUBE. DURING CASE, THERE WAS LOSS OF ETCO2 AND PATIENT BRIEFLY DESATURATED PRIOR TO THE DISCOVERY OF A TEAR IN THIS CONNECTOR". NO PATIENT INJURY OR HARM REPORTED. NO FURTHER INFORMATION PROVIDED ON PATIENT CONDITION.

  Patient problems: Low Oxygen Saturation

  MAUDE report 12924220 ↗
• MalfunctionDec 1, 2021Fracture; Fracture

  IT WAS REPORTED "SMALL DEFECT/CRACK IN THE CORRUGATED EXTENSION TUBING". UNKNOWN WHEN ISSUE WAS FIRST IDENTIFIED. SPECIFIC PATIENT INFORMATION UNKNOWN AT TIME OF REPORTING.

  Patient problems: Insufficient Information

  MAUDE report 12912862 ↗
• InjuryNov 30, 2021Fracture; Fracture

  IT WAS REPORTED "THERE WAS AN ANESTHESIA STAT IN THE OR THIS WEEK RELATED TO DECREASED ETCO2/CIRCUIT LEAK THAT OCCURRED IN THE MIDDLE OF A CASE THAT WAS ULTIMATELY TRACED TO A SMALL DEFECT/CRACK IN THE CORRUGATED EXTENSION TUBING". THE CUSTOMER CONFIRMED "COMPLETE INABILITY TO VENTILATE" AND REQUIRED MEDICAL INTERVENTION. THE MEDICAL INTERVENTION WAS REPORTED AS BEING AN "INVASIVE PROCEDURE" ALTHOUGH NO SPECIFIC DETAILS WERE REPORTED. PATIENT CONDITION IS UNKNOWN.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 12902219 ↗
• MalfunctionNov 30, 2021Fracture; Fracture

  IT WAS REPORTED "SMALL DEFECT/CRACK IN THE CORRUGATED EXTENSION TUBING REPORTED VIA SAFETY REPORTING MECHANISMS". UNKNOWN WHEN ISSUE WAS FIRST IDENTIFIED. SPECIFIC PATIENT INFORMATION UNKNOWN AT TIME OF REPORTING.

  Patient problems: Insufficient Information

  MAUDE report 12901948 ↗
• MalfunctionNov 30, 2021Fracture; Fracture

  IT WAS REPORTED "THERE WAS AN ANESTHESIA STAT IN THE OR THIS WEEK RELATED TO DECREASED ETCO2/CIRCUIT LEAK THAT OCCURRED IN THE MIDDLE OF A CASE THAT WAS ULTIMATELY TRACED TO A SMALL DEFECT/CRACK IN THE CORRUGATED EXTENSION TUBING". SPECIFIC PATIENT INFORMATION UNKNOWN AT TIME OF REPORTING.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 12901684 ↗
• MalfunctionNov 30, 2021Fracture; Fracture

  IT WAS REPORTED "THERE WAS AN ANESTHESIA STAT IN THE OR THIS WEEK RELATED TO DECREASED ETCO2/CIRCUIT LEAK THAT OCCURRED IN THE MIDDLE OF A CASE THAT WAS ULTIMATELY TRACED TO A SMALL DEFECT/CRACK IN THE CORRUGATED EXTENSION TUBING". SPECIFIC PATIENT INFORMATION UNKNOWN AT TIME OF REPORTING.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 12901678 ↗
• MalfunctionNov 30, 2021Fracture; Fracture

  IT WAS REPORTED "THERE WAS AN ANESTHESIA STAT IN THE OR THIS WEEK RELATED TO DECREASED ETCO2/CIRCUIT LEAK THAT OCCURRED IN THE MIDDLE OF A CASE THAT WAS ULTIMATELY TRACED TO A SMALL DEFECT/CRACK IN THE CORRUGATED EXTENSION TUBING". SPECIFIC PATIENT INFORMATION UNKNOWN AT TIME OF REPORTING.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 12901580 ↗