Stylet, Tracheal Tube
FDA adverse event reports and recall history for stylet, tracheal tube (product code BSR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 506
- Deaths
- 10
- Injuries
- 132
- Malfunctions
- 335
Reports per year
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
- 2024-11-25Open, ClassifiedUnder Investigation by firm
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
- 2024-11-25Open, ClassifiedUnder Investigation by firm
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
- 2024-11-25Open, ClassifiedUnder Investigation by firm
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
- 2016-10-11TerminatedNonconforming Material/Component
The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.
The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.
- 2015-11-06TerminatedUnknown/Undetermined by firm
Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
- 2015-11-06TerminatedUnknown/Undetermined by firm
Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
- 2015-04-30TerminatedPackaging
CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure.
Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
- 2015-04-30TerminatedPackaging
Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
- 2015-02-04TerminatedProcess control
Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients.
A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.
- 2012-01-11TerminatedPending
Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex Medical Sdn Bhd, P.O. Box, Industrial Estate, 24600 Kamunting, Perak, Malaysia. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
Complaints of difficulty removing stylet from the endotracheal tube and possible PVC sheath separation were received.
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