RUSCH IPN041502Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 14026704341426), received between Apr 26, 2021 and Jun 12, 2026 — classified as 5 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (8 reports).

2 FDA recall records name this device's identifier, 2 still open.

34 other recalls cover devices cleared under the same FDA submission (K961837); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 25, 2023Open, Classified

   Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

   Z-1888-2023 · Root cause: Under Investigation by firm · FDA record ↗

2. Dec 8, 2022Open, Classified

   Potential for pilot balloon non-inflation or cuff non-deflation.

   Z-1011-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Material Too Rigid or Stiff

  IT WAS REPORTED THAT "THE TIP OF THE TUBES ARE VERY STIFF, CONCERN ABOUT UNNECESSARY TRAUMA TO CORDS/LARYNX. THE BALLOON IS ALSO STIFF AND DIFFICULT TO PASS THROUGH THE CORDS. CATCHES ON THE CORDS WHEN TRYING TO ADVANCE THE TUBE." ADDITIONAL INFORMATION RECEIVED ON MAY 21, 2026, INDICATED THAT "THE ISSUE OCCURRED ON GOING FROM MID APRIL UNTIL NOW, DURING USE IN PATIENT, HAVING TO HAVE MULTIPLE ATTEMPTS TO INTUBATE. SORE THROATS BEING REPORTED MORE OFTEN THAN USUAL. PATIENT'S CURRENT CONDITION UNKNOWN, MULTIPLE PATIENTS INVOLVED."

  Patient problems: Sore Throat

  MAUDE report 25491000 ↗
• MalfunctionJan 15, 2026Inflation Problem

  IT WAS REPORTED THAT: "THERE WAS NO AIR VISIBLE IN THE PILOT BALLOON...WHEN WE INFLATED THE CUFF (OUTSIDE THE PATIENT), IT FILLED WITH AIR DESPITE THE PILOT BALLOON NOT INFLATING. WE FIGURED IT WAS A FAULTY TUBE." ASSOCIATED COMPLAINTS: 8040412-2026-00011 AND 8040412-2026-00012.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079422 ↗
• MalfunctionJan 15, 2026Inflation Problem

  IT WAS REPORTED THAT: "THERE WAS NO AIR VISIBLE IN THE PILOT BALLOON...WHEN WE INFLATED THE CUFF (OUTSIDE THE PATIENT), IT FILLED WI TH AIR DESPITE THE PILOT BALLOON NOT INFLATING. WE FIGURED IT WAS A FAULTY TUBE." ASSOCIATED COMPLAINTS: 8040412-2026-00011 AND 8040412-2026-00012.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079416 ↗
• MalfunctionJun 26, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT: "DIFFICULT LARYNGOSCOPY. VERY EASY BAG MASK VENTILATION (BMV). NARROW MOUTH AND ANTERIOR LARYNX. 2 X LARYNGOSCOPY AND ESOPHAGEAL INTUBATIONS WERE ATTEMPTED. VIEW WITHOUT BACKWARD, UPWARD, RIGHTWARD PRESSURE MANEUVER (BURP). EASY BMV IN BETWEEN ATTEMPTS. SEVO TO MAINTAIN DEPTH PLUS EXTRA PROPOFOL BOLUSES WERE GIVEN. SUCCESSFUL STYLETTED, 7.0 RUSCH TELEFLEX (HIGH-VOLUME, LOW-PRESSURE CUFF) ETT PLACED. OROPHARYNX SUCTIONED FOR SMALL AMOUNT OF BLOOD. NOTED PROMINENT ESOPHAGEAL OPENING (LIKELY FROM BALLOON INFLATION X 2) WITHOUT BLEEDING OR OBVIOUS TEAR. DUE TO FACT THAT ESOPHAGEAL INTUBATION X 2- THORACIC SURGERY CALLED TO REVIEW WITH SCOPE AND RULE OUT PERFORATION/TEAR. NO SUBCUTANEOUS EMPHYSEMA NOTED. THE RUSCH ENDOTRACHEAL TUBES ARE MADE OF A MATERIAL THAT IS SUBSTANTIALLY LESS MALLEABLE THAN THE REGULAR PREFERRED ENDOTRACHEAL TUBES AND AS SUCH ARE MORE LIKELY TO CAUSE INJURY TO THE SOFT TISSUES OF THE PHARYNX DURING INTUBATION. THE PATIENT WAS REPORTED AS FINE POST PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22335458 ↗
• InjuryJun 13, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "THE DEVICE WAS SOFTENING, TWISTING AND KINKING WHILE THE PATIENT WAS IN PRONE POSITION DURING SURGERY. NO HARM TO THE PATIENT, BUT INCREASED AIRWAY PRESSURE PROMPTED INVESTIGATION WHICH REVEALED A BLOCKED ENDOTRACHEAL TUBE. IT DELAYED SURGERY BECAUSE THE SURGEON HAD TO REPOSITION HEAD STABILIZER TO ALLOW REPOSITIONING OF THE ENDOTRACHEAL TUBE TO "UNKINK" IT. PATIENT DESATED TO UNDER 95%, HOWEVER NOT PROLONGED, NO PATIENT HARM. IMMEDIATE INTERVENTION BY THE ANESTHESIA MEDICAL PERSONNEL RESOLVED THE ISSUE."

  Patient problems: Low Oxygen Saturation

  MAUDE report 22201885 ↗
• InjuryJun 10, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT: "PATIENT WAS EXTUBATED MID-CASE REQUIRING EMERGENT REINTUBATION. VENTILATOR TOUCH-SCREEN FAILED TO RESPOND WHICH PREVENTED INCREASING FLOWS, DELAYING ABILITY TO BMV. SUBSEQUENTLY UNABLE TO BMV, PATIENT EMERGENTLY REINTUBATED BUT ETT-TO-CIRCUIT CONNECTOR FELL OFF. VERY CHALLENGING TO OPEN NEW ETT TO OBTAIN A NEW CONNECTOR. DURING THIS TIME PATIENT'S SPO2 DROPPED TO 30-40S AS UNABLE TO PROVIDE O2 WITH LOSS OF CONNECTOR." THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22174735 ↗
• MalfunctionApr 30, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT: "UPON VISUAL INSPECTION, ONE OF THE SAMPLES ANALYZED WAS IDENTIFIED AS HAVING AN IRREGULAR SURFACE SENSITIVE TO TOUCH. FAILURE TO MEET ACCEPTANCE LIMITS FOR DIMENSION S1 FOR THE MAGILL TYPE ENDOTRACHEAL TUBE". ASSOCIATED COMPLAINTS 8040412-2025-00122.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932727 ↗
• MalfunctionApr 29, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT: "UPON VISUAL INSPECTION, ONE OF THE SAMPLES ANALYZED WAS IDENTIFIED AS HAVING AN IRREGULAR SURFACE SENSITIVE TO TOUCH. FAILURE TO MEET ACCEPTANCE LIMITS FOR DIMENSION S1 FOR THE MAGILL TYPE ENDOTRACHEAL TUBE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925212 ↗
• MalfunctionApr 9, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT: "I USED RUSCH 7.0 ENDOTRACHEAL TUBE TO INTUBATE MY PATIENT. I THINK THESE TUBES ARE A SUBSTITUTION OR REPLACEMENT FOR OUR REGULAR ENDOTRACHEAL TUBES. I FOUND THEM INCREDIBLY STIFF RESULTING IN MORE DIFFICULTY IN INTUBATING PATIENTS AND HAVING AN INCREASED RISK OF AIRWAY TRAUMA. THEY ALSO MAKE USING VIDEO LARYNGOSCOPY MORE DIFFICULT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21803951 ↗
• MalfunctionSep 3, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT: " 7.0 TELEFLEX CUFFED ETT CAUSE SOFT TISSUE TRAUMA TO THE AIRWAY DUE TO THEIR STIFFNESS. THE CUFFS ARE NOT IDEAL.".

  Patient problems: Abrasion

  MAUDE report 20123353 ↗
• MalfunctionSep 3, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT: "7.0 ET IS TOO HARD , RIGID, NOT COMPLIANT WITH PT'S TISSUE, INCREASED RISK OF TRAUMA OR BLEEDING IN THE ORAL AIRWAY." THE ISSUE WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20123319 ↗
• MalfunctionJul 31, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT IS REPORTED THAT: "SUBSTITUTE PRODUCT IS TOO LONG SO GLIDESCOPE STYLET DOES NOT REACH THE DISTAL END OF ETT, PRODUCT IS TOO STIFF OF PLASTIC CAUSING TRAMA TO AIRWAYS, PRODUCT'S ETT ADAPTOR EASILY DISCONNECTS, PRODUCT DIFFICULT TO REMOVE FROM PACKAGING WITHOUT CONTAMINATING. THERE WAS NO REPORTED PATIENT HARM." ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19870331 ↗
• MalfunctionJul 31, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT IS REPORTED THAT: "SUBSTITUTE PRODUCT IS TOO LONG SO GLIDESCOPE STYLET DOES NOT REACH THE DISTAL END OF ETT, PRODUCT IS TOO STIFF OF PLASTIC CAUSING TRAMA TO AIRWAYS, PRODUCT'S ETT ADAPTOR EASILY DISCONNECTS, PRODUCT DIFFICULT TO REMOVE FROM PACKAGING WITHOUT CONTAMINATING. THERE WAS NO REPORTED PATIENT HARM." ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19870311 ↗
• MalfunctionJul 31, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT IS REPORTED THAT: "SUBSTITUTE PRODUCT IS TOO LONG SO GLIDESCOPE STYLET DOES NOT REACH THE DISTAL END OF ETT, PRODUCT IS TOO STIFF OF PLASTIC CAUSING TRAUMA TO AIRWAYS, PRODUCT'S ETT ADAPTOR EASILY DISCONNECTS, PRODUCT DIFFICULT TO REMOVE FROM PACKAGING WITHOUT CONTAMINATING. THERE WAS NO REPORTED PATIENT HARM." ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19870001 ↗
• MalfunctionJul 30, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED "RUSCH '7.0 ENDOTRACHEAL TUBE INSERTED WITHOUT ISSUE, UNABLE TO VENTILATE MECHANICALLY OR MANUALLY. HIGH PRESSURE ALARMS PRESENT." THE PATIENT WAS REINTUBATED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19861308 ↗
• MalfunctionMar 29, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED: "THE ENDOTRACHEAL TUBES ARE VERY STIFF WHICH CAUSES AIRWAY INJURIES UPON INSERTION, REQUIRING THE PATIENT TO BE REINTUBATED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER 8040412-2024-00059.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19002550 ↗
• MalfunctionMar 4, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED "IT WAS NOTED THE TUBE WAS VERY DIFFICULT TO PLACE DUE TO ITS RIGID NATURE. ONCE INSERTED SUCCESSFULLY THE CUFF HAD TORN AND THE PATIENT REQUIRED IMMEDIATE REINTUBATION. THIS PATIENT WAS A DIFFICULT INTUBATION." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER 8040412-2024-00058.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825324 ↗
• MalfunctionMar 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT: ON (B)(6) 2024 IT WAS NOTED THE TUBE WAS VERY DIFFICULT TO PLACE DUE TO ITS RIGID NATURE. ONCE INSERTED SUCCESSFULLY THE CUFF HAD TORN AND THE PATIENT REQUIRED IMMEDIATE REINTUBATION. THIS PATIENT WAS A DIFFICULT INTUBATION. ASSOCIATED COMPLAINTS 8040412-2024-00059.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18824976 ↗
• MalfunctionMay 30, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE ANESTHESIOLOGIST SPRAYED THE CANNULA WITH LIDOCAINE AS "COMMON PRACTICE TO RELAX THE TISSUE AND REDUCE INFLAMMATION" WHICH CAUSED THE PRINTED INK MARKINGS ON THE ETT TO COME OFF. A 2ND CANNULA WAS USED AND SPRAYED WITH LIDOCAINE WHICH CAUSED THE SAME EFFECT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17018894 ↗
• MalfunctionMay 30, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE ANESTHESIOLOGIST SPRAYED THE CANNULA WITH LIDOCAINE AS "COMMON PRACTICE TO RELAX THE TISSUE AND REDUCE INFLAMMATION" WHICH CAUSED THE PRINTED INK MARKINGS ON THE ETT TO COME OFF. A 2ND CANNULA WAS USED AND SPRAYED WITH LIDOCAINE WHICH CAUSED THE SAME EFFECT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17018885 ↗
• MalfunctionMar 28, 2023Leak/Splash; Leak/Splash

  REPORTED ISSUE: THE BALLOON OF THE ENDOTRACHEAL TUBE WAS DEFLATED CAUSING A LEAK OF THE SYSTEM. THEY PROCEED TO REINTUBATION, CHECK THE PRESSURE POSITION OF THE BALLOON AND THE ANAESTHESIA PROCEDURE IS RESUMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629662 ↗
• MalfunctionJan 31, 2023Disconnection; Disconnection

  IT IS REPORTED THAT "ON MULTIPLE OCCASIONS, WHILE IN THE MIDDLE OF A SURGICAL CASE, THE DETACHABLE PLASTIC PIECE ON THE TOP OF THE E NDOTRACHEAL TUBE HAS COME OFF COMPLETELY WITH THE CIRCUIT ATTACHED WHILE THE PATIENT IS INTUBATED. LAST WEEK THIS HAPPENED TWICE IN THE MIDDLE OF OUR FIRST CASE." AFTER FURTHER CORRESPONDENCE WITH THE REPORTER, THE CUSTOMER DOES NOT HAVE ANY FURTHER INFORMATION REGARDING THE SPECIFICS OF THE EVENTS. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDRS 8040412-2023-00046, 8040412-2023-00047, 8040412-2023-00048, 8040412-2023-00049

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272875 ↗
• MalfunctionJan 31, 2023Disconnection; Disconnection

  IT IS REPORTED THAT "ON MULTIPLE OCCASIONS, WHILE IN THE MIDDLE OF A SURGICAL CASE, THE DETACHABLE PLASTIC PIECE ON THE TOP OF THE E NDOTRACHEAL TUBE HAS COME OFF COMPLETELY WITH THE CIRCUIT ATTACHED WHILE THE PATIENT IS INTUBATED. LAST WEEK THIS HAPPENED TWICE IN THE MIDDLE OF OUR FIRST CASE." AFTER FURTHER CORRESPONDENCE WITH THE REPORTER, THE CUSTOMER DOES NOT HAVE ANY FURTHER INFORMATION REGARDING THE SPECIFICS OF THE EVENTS. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDRS 8040412-2023-00046, 8040412-2023-00047, 8040412-2023-00025, AND 8040412-2023-00049.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272685 ↗
• MalfunctionDec 3, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON IN THE TUBE DOES NOT INFLATE PROPERLY, SO IT MUST BE DONE MANUALLY EVERY TIME, FAILURE TO INFLATE PROPERLY MAY CAUSE THE EQUIPMENT TO BREAK OUT WHICH MAY RESULT IN LOSS OF AIR SUPPLY. NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15912210 ↗
• MalfunctionDec 3, 2022Inflation Problem; Inflation Problem

  REPORTED ISSUE: THE BALLOON IN THE TUBE DOES NOT INFLATE CORRECTLY, SO THE NURSE MUST INFLATE IT MANUALLY, WHICH DOES NOT INFLATE PROPERLY AND MAY CAUSE THE TUBING EQUIPMENT TO LEAVE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15912156 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961837. One submission often covers many models, so check the product and lot details in each record.

• Z-1893-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095
• Z-1963-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080
• Z-1847-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560
• Z-1851-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580
• Z-1889-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075
• Z-1882-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095
• Z-1881-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055
• Z-1849-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570
• Z-1959-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060
• Z-1965-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080090
• Z-1883-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100
• Z-1899-2023 · May 25, 2023 · Open, Classified
  RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045
• Z-1892-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090
• Z-1961-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080070
• Z-1884-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050

…and 19 more.