RUSCHRecalls & reported problems across all models

We found 220 models of RUSCH by Teleflex Incorporated in the FDA's device registry (GUDID). Together they are named in 436 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2018 and Aug 17, 2026 — classified as 2 deaths, 23 injuries, 411 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (42 reports).

130 FDA recall records name at least one of these models by its device identifier, 125 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

RUSCH recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 25, 2023Open, Classified

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

   Z-1905-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 25, 2023Open, Classified

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

   Z-1904-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. May 25, 2023Open, Classified

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

   Z-1903-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. May 25, 2023Open, Classified

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

   Z-1902-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. May 25, 2023Open, Classified

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

   Z-1901-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. May 25, 2023Open, Classified

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

   Z-1900-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. May 25, 2023Open, Classified

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

   Z-1899-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. May 25, 2023Open, Classified

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

   Z-1898-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

9. May 25, 2023Open, Classified

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

   Z-1897-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

10. May 25, 2023Open, Classified

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

    Z-1896-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. May 25, 2023Open, Classified

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

    Z-1895-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

12. May 25, 2023Open, Classified

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

    Z-1894-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

13. May 25, 2023Open, Classified

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

    Z-1893-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

14. May 25, 2023Open, Classified

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

    Z-1892-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

15. May 25, 2023Open, Classified

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

    Z-1891-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

16. May 25, 2023Open, Classified

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

    Z-1890-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

17. May 25, 2023Open, Classified

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

    Z-1889-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

18. 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 · Recall details · FDA record ↗

19. May 25, 2023Open, Classified

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

    Z-1887-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

20. May 25, 2023Open, Classified

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

    Z-1886-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

21. May 25, 2023Open, Classified

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

    Z-1885-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

22. May 25, 2023Open, Classified

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

    Z-1884-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

23. May 25, 2023Open, Classified

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

    Z-1883-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

24. May 25, 2023Open, Classified

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

    Z-1882-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

25. May 25, 2023Open, Classified

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

    Z-1965-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

26. May 25, 2023Open, Classified

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

    Z-1964-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

27. May 25, 2023Open, Classified

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

    Z-1963-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

28. May 25, 2023Open, Classified

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

    Z-1961-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

29. May 25, 2023Open, Classified

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

    Z-1960-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

30. May 25, 2023Open, Classified

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

    Z-1959-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

…and 100 older recalls, listed on each model's page.

Most reported RUSCH problems

RUSCH models

220 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• RUSCH IPN041476

  Tube, tracheal (w/wo connector)
  10 recalls0 reports
• RUSCH IPN041502

  Tube, tracheal (w/wo connector)
  2 recalls30 reports
• RUSCH IPN041504

  Tube, tracheal (w/wo connector)
  2 recalls8 reports
• RUSCH IPN041503

  Tube, tracheal (w/wo connector)
  2 recalls4 reports
• RUSCH IPN041498

  Tube, tracheal (w/wo connector)
  2 recalls2 reports
• RUSCH IPN042742

  Tube, tracheal (w/wo connector)
  2 recalls1 report
• RUSCH IPN044687

  Tube, tracheal (w/wo connector)
  2 recalls1 report
• RUSCH IPN041501

  Tube, tracheal (w/wo connector)
  2 recalls1 report
• RUSCH IPN041505

  Tube, tracheal (w/wo connector)
  2 recalls1 report
• RUSCH IPN042739

  Tube, tracheal (w/wo connector)
  2 recalls0 reports
• RUSCH IPN042741

  Tube, tracheal (w/wo connector)
  2 recalls0 reports
• RUSCH IPN042743

  Tube, tracheal (w/wo connector)
  2 recalls0 reports
• RUSCH IPN042744

  Tube, tracheal (w/wo connector)
  2 recalls0 reports
• RUSCH IPN042745

  Tube, tracheal (w/wo connector)
  2 recalls0 reports
• RUSCH IPN044681

  Tube, tracheal (w/wo connector)
  2 recalls0 reports
• RUSCH IPN044683

  Tube, tracheal (w/wo connector)
  2 recalls0 reports
• RUSCH IPN044688

  Tube, tracheal (w/wo connector)
  2 recalls0 reports
• RUSCH IPN044689

  Tube, tracheal (w/wo connector)
  2 recalls0 reports
• RUSCH IPN041499

  Tube, tracheal (w/wo connector)
  2 recalls0 reports
• RUSCH IPN041500

  Tube, tracheal (w/wo connector)
  2 recalls0 reports
• RUSCH IPN041507

  Tube, tracheal (w/wo connector)
  2 recalls0 reports
• RUSCH IPN044686

  Tube, tracheal (w/wo connector)
  1 recall14 reports
• RUSCH IPN041448

  Tube, tracheal (w/wo connector)
  1 recall11 reports
• RUSCH IPN042498

  Tube, tracheal (w/wo connector)
  1 recall10 reports
• RUSCH IPN041544

  Tube, tracheal (w/wo connector)
  1 recall5 reports
• RUSCH IPN044685

  Tube, tracheal (w/wo connector)
  1 recall4 reports
• RUSCH IPN041443

  Tube, tracheal (w/wo connector)
  1 recall4 reports
• RUSCH IPN041444

  Tube, tracheal (w/wo connector)
  1 recall2 reports
• RUSCH IPN041447

  Tube, tracheal (w/wo connector)
  1 recall2 reports
• RUSCH IPN044694

  Tube, tracheal (w/wo connector)
  1 recall1 report
• RUSCH IPN040775

  Tube, tracheal (w/wo connector)
  1 recall1 report
• RUSCH IPN040776

  Tube, tracheal (w/wo connector)
  1 recall1 report
• RUSCH IPN041426

  Tube, tracheal (w/wo connector)
  1 recall1 report
• RUSCH IPN914318

  Tube, tracheal (w/wo connector)
  1 recall1 report
• RUSCH IPN042737

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN042738

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN042740

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN042746

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN042735

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN042494

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN042495

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN042496

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN042497

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN042501

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN050116

  CATHETER, UROLOGICAL
  1 recall0 reports
• RUSCH IPN044682

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN044684

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN044692

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN044693

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN044695

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN044696

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN044697

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040696

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040697

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040698

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040699

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040700

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040701

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040702

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040703

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040704

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040713

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040715

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040716

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040717

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040718

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040719

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040720

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040753

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040754

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040755

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040756

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040757

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040758

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040759

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040760

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040761

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040774

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040777

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040778

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040779

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040780

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040781

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN040782

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041419

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041420

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041421

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041422

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041423

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041424

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041425

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041427

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041428

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041429

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041430

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041441

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041442

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041445

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041446

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• RUSCH IPN041449

  Tube, tracheal (w/wo connector)
  1 recall0 reports

Recent RUSCH adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286813 ↗
• MalfunctionAug 17, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286731 ↗
• MalfunctionAug 17, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286695 ↗
• MalfunctionAug 17, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286448 ↗
• MalfunctionAug 12, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225570 ↗
• InjuryAug 11, 2026Physical Resistance/Sticking

  Patient problems: Urinary Tract Infection

  MAUDE report 50212697 ↗
• MalfunctionJun 30, 2026Gas/Air Leak

  IT WAS REPORTED THAT "THE CUFF AND THE PILOT BALLOON SEEM TO BE TRANSFERRING THE AIR BETWEEN EACH OTHER. THE PILOT BALLOON DOESN'T RETAIN ANY AIR, AND ETT CUFF STARTED TO DEFLATE WHILE IN PATIENT. CUSTOMER WENT A DIFFERENT DIRECTION TO COMPLETE THE PROCEDURE." NO PATIENT INJURY OR CONSEQUENCE REPORTED, NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S STATUS IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669503 ↗
• 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 ↗
• MalfunctionMay 27, 2026Sharp Edges

  IT WAS REPORTED THAT "BLADE SIZE 0 IS LARGER IN DIAMETER THAN EXPECTED, THE END/TIP OF THE BLADE IS WIDER AND SHARP. THE BLADE DESIGN DOES NOT ACCURATELY MATCH THE STANDARD MILLER BLADE PROFILE. AN OVA HAS BEEN RAISED AFTER A FAILED INTUBATION CASE (TWO UNSUCCESSFUL ATTEMPTS), RESULTING IN PATIENT COMPROMISE." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026, INDICATED THAT "NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT, PATIENT'S CURRENT CONDITION IS GOOD. NO MEDICAL INTERVENTION REQUIRED. A VERY SHARP EDGE OF THE LARYNGOSCOPE IS OBSERVED, AND THE END-USERS BELIEVE THAT THE FAILED INTUBATION IS BECAUSE OF THE SHARP BACK EDGE OF THE LARYNGOSCOPE AND DIMENSIONAL DIFFERENCES. BOTH FAILED INTUBATION ATTEMPTS WERE ON THE SAME PATIENT. THE REPORTED DESIGN AND DIMENSIONAL DIFFERENCES WERE IDENTIFIED AFTER INTUBATION FAILURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311068 ↗
• MalfunctionMay 21, 2026Peeled/Delaminated

  IT WAS REPORTED THAT "POLARIS BLADE COATING COMING OFF DURING INTUBATION." NO PATIENT INJURY OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250219 ↗
• MalfunctionMay 18, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT "TODAY WE EXPERIENCED PROBLEMS WITH CUFF LEAKAGE ON 2 TUBES OF THE SAME SIZE. WE UNDERSTAND THAT THIS CAN OCCUR DURING NASAL INTUBATION, BUT WE WERE SURPRISED THAT IT HAPPENED TWICE IN A ROW WITH THE SAME PATIENT AND BATCH. MY COLLEAGUE TESTED THE CUFFS OF BOTH TUBES BEFORE INTUBATION ACCORDING TO ROUTINE, AND SHE DESCRIBES IT AS WHEN SHE INFLATED THE CUFF, THERE WAS NO RESISTANCE. WE CHECKED THE LEAKAGE AFTERWARDS AND FOUND HOLES IN THE SAME LOCATIONS ON BOTH TUBES, IN THE UPPER PART OF THE CUFF." ADDITIONAL INFORMATION RECEIVED ON MAY 12, 2026, INDICATED THAT "WE REALISED THAT THE CUFF OF THE TUBE WAS NOT HOLDING TIGHT WHEN TRYING TO CUFF THE TUBES CUFF, MOMENTA DEFLATION, SO WE REMOVED THE DEFECT TUBE, AND A NEW ONE WAS TESTED. THE DEFECT TUBE WAS NEVER IN USE PRE-SURGERY AND NEVER CONNECTED TO THE RESPIRATOR. THE 3RD TUBE WE USED WORKED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT STATUS IS REPORTED AS "FINE." TWO DEVICES REPORTED. ASSOCIATED MDRS: 8040412-2026-00074.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210854 ↗
• MalfunctionMay 18, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT "TODAY WE EXPERIENCED PROBLEMS WITH CUFF LEAKAGE ON 2 TUBES OF THE SAME SIZE. WE UNDERSTAND THAT THIS CAN OCCUR DURING NASAL INTUBATION, BUT WE WERE SURPRISED THAT IT HAPPENED TWICE IN A ROW WITH THE SAME PATIENT AND BATCH. MY COLLEAGUE TESTED THE CUFFS OF BOTH TUBES BEFORE INTUBATION ACCORDING TO ROUTINE, AND SHE DESCRIBES IT AS WHEN SHE INFLATED THE CUFF, THERE WAS NO RESISTANCE. WE CHECKED THE LEAKAGE AFTERWARDS AND FOUND HOLES IN THE SAME LOCATIONS ON BOTH TUBES, IN THE UPPER PART OF THE CUFF." ADDITIONAL INFORMATION RECEIVED ON MAY 12, 2026, INDICATED THAT "WE REALISED THAT THE CUFF OF THE TUBE WAS NOT HOLDING TIGHT WHEN TRYING TO CUFF THE TUBE'S CUFF, MOMENTAN DEFLATION, SO WE REMOVED THE DEFECTIVE TUBE, AND A NEW ONE WAS TESTED. THE DEFECT TUBE WAS NEVER IN USE PRE-SURGERY AND NEVER CONNECTED TO THE RESPIRATOR. THE 3RD TUBE WE USED WORKED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE." TWO DEVICES REPORTED. ASSOCIATED MDRS: 8040412-2026-00074.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210773 ↗
• MalfunctionMay 13, 2026Gas/Air Leak

  IT WAS REPORTED THAT "AFTER INTUBATION INTO THE PATIENT. FOUND CUFF LEAK. THE DOCTOR REMOVED IT AND PLACED A NEW ETT." ADDITIONAL INFORMATION RECEIVED ON APRIL 21, 2026, INDICATED THAT "AFTER PLACEMENT, THE LEAK WAS DETECTED DURING VENTILATION, AND THE ETT WAS REPLACED. THE PATIENT DID NOT HAVE DESATURATION DUE TO THE DEFECT. THE DEVICE WAS PRE-TESTED ACCORDING TO THE IFU. THE PATIENT IS STABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165182 ↗
• MalfunctionMay 8, 2026Material Too Rigid or Stiff

  IT WAS REPORTED THAT "ETT TUBES ARE TOO STIFF, ARE EASILY KINKED OFF, AND THE CONNECTOR FALLS OFF EASILY." NO PATIENT INVOLVEMENT. 3 ISSUES REPORTED. ASSOCIATED MDRS:8040412-2026-00063, 8040412-2026-00056.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129109 ↗
• MalfunctionMay 8, 2026Decoupling

  IT WAS REPORTED THAT "ETT TUBES ARE TOO STIFF, ARE EASILY KINKED OFF, AND THE CONNECTOR FALLS OFF EASILY." NO PATIENT INVOLVEMENT. 3 ISSUES REPORTED. ASSOCIATED MDRS:8040412-2026-00063, AND 8040412-2026-00057.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128850 ↗

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