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BTRClass 2

Tube, Tracheal (W/Wo Connector)

FDA adverse event reports and recall history for tube, tracheal (w/wo connector) (product code BTR), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
18,987
Deaths
255
Injuries
3,789
Malfunctions
14,537

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2025-03-12Open, ClassifiedProcess change control

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

  • 2024-05-28Open, ClassifiedUnder Investigation by firm

    Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID; (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID; (4) REF DYNJ18875, Polyurethane Cuff 7.5 mm ID; (5) REF DYNJ18880, Polyurethane Cuff 8.0 mm ID; and (6) REF DYNJ18885, Polyurethane Cuff 8.5 mm ID. Medline SubG Endotracheal Tube with Subglottic Suctioning packaged into the following convenience kits: (1) Medline Intubation Kit - Drawer 3, Reorder No. ACC010502, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case; (2) Medline Intubation Tube - Drawer 3, Reorder No. ACC010527, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case; (3) Medline Adult Intubation, Reorder No. ACC010540, containing 8.5 size subglottic cuff, 3 kits/case; (4) Medline Adult Intubation, Reorder No. ACC010540A, containing 8.5 size subglottic cuff, 3 kits/case; (5) Medline Airway Kit - Drawer 3, Reorder No. ACC010717, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 3 kits/case; (6) Medline Airway Kit, Reorder No. DYNDJ1132, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 26 kits/case; (7) Medline Adult Intubation W Evac, Reorder No. DYNDJ1133, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 10 kits/case; (8) Medline Backup Kit, Reorder No. DYNJ909501, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package; (9) Medline Backup Kit, Reorder No. DYNJ909501A, containing 6.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package; (10) Medline Adult Intubation Tray, Reorder No. DYNJAA269, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 10 kits/case.

    Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.

  • 2023-06-29Open, ClassifiedUnder Investigation by firm

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050

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

  • 2023-06-29Open, ClassifiedUnder Investigation by firm

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055

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

  • 2023-06-29Open, ClassifiedUnder Investigation by firm

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060

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

  • 2023-06-29Open, ClassifiedUnder Investigation by firm

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065

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

  • 2023-06-29Open, ClassifiedUnder Investigation by firm

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170070

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

  • 2023-06-29Open, ClassifiedUnder Investigation by firm

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075

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

  • 2023-06-29Open, ClassifiedUnder Investigation by firm

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080

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

  • 2023-06-29Open, ClassifiedUnder Investigation by firm

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085

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

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