Doyle II ™ 1524050Recalls & reported problems
Medtronic Xomed, Inc. · SPLINT 1524050 5PK PAIR DOYLE II AIRWAY · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20681490041892), received between Oct 15, 2018 and Oct 15, 2018 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bacterial Infection1
- Sepsis1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT CAME BACK TO THE EMERGENCY ROOM OF THE FACILITY WITH "ECBOLI" FROM THE PACKING AND SPLINT IMPLANTS.
Patient problems: Bacterial Infection; Sepsis; Unspecified Infection
MAUDE report 7964784 ↗
Other SPLINT, INTRANASAL SEPTAL devices
- Nasopore 5400030008Stryker Corporation · SPLINT, INTRANASAL SEPTAL2 recalls1 report
- Nasopore 5400010008Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall4 reports
- Nasopore 5400020108Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall3 reports
- Hemopore 5400020208Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall3 reports
- Nasopore 5400222004SStryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400010004Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400020004Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400030004Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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