FDA Device Intelligence
Home › TRUER MEDICAL, INC. › Adult Stylet

Adult Stylet

TRUER MEDICAL, INC. · Model 90200 · UDI-DI 00859290006342

BSR Prescription
10
510(k) clearances
507
Adverse events (10 deaths)
16
Recalls
137
Facilities

Description

The Truer Medical disposable Intubation Stylet is the most adaptable, cost-effective stylet available on the market. Each stylet contains malleable wire encased in a specially designed PVC sheath which allows the Truer Medical Stylet to be used in a wide range of Endotracheal Tube (ETT) sizes while still maintaining the shape you require. With just two stylet sizes in your inventory, all ETT sizes are covered, simplifying inventory control and ordering. A unidirectional end cap doesn’t permit the stylet to advance forward during the intubation process, significantly lowering the risk of unnecessary trauma to the patient. Simply install the stylet into the ETT and engage the unidirectional end cap onto the 15mm ETT connector. Draw the frosted PVC coated wire back to the desired location, shape the ETT, and you are ready to intubate. This assures a procedure that is fast, efficient, and—most importantly—safe.

Recalls

DateFirmReason
2024-10-28Smiths Medical ASD, Inc.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 tu
2024-10-28Smiths Medical ASD, Inc.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 tu
2024-10-28Smiths Medical ASD, Inc.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 tu
2017-05-11Teleflex MedicalProduct size listed on the labeling is incorrect.
2016-08-19Brathwaites Oliver MedicalThe Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.
2015-08-24Teleflex MedicalDue to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
2015-08-24Teleflex MedicalDue to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
2015-03-13Vital Signs Colorado Inc.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 steri
2015-03-13Vital Signs Colorado Inc.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 steri
2014-12-23Cardinal HealthA small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.