Edge SDK4450-FTRecalls & reported problems
Covidien LP · Firm Tip; Endobronchial Procedure Kit;45 Catheter · Class 2
All models of Edge (43)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521545564), received between Apr 3, 2019 and Nov 6, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
- Patient Data Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2024Use of Device Problem; Patient Data Problem; Use of Device Problem; Patient Data Problem
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LOCATABLE GUIDE HAD INABILITY TO DEFLECT TIP. DUE TO THIS, THE PATIENT COULD NOT REGISTER DURING THE WORKFLOW. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THECASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20617039 ↗MalfunctionApr 3, 2019Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN PHYSICIAN WENT TO SAMPLE USING A NEEDLE A PLASTIC STRINGY SUBSTANCE WAS EXPELLED FROM DISTAL END OF CATHETER. PHYSICIAN RETRIEVED THE STRINGY SUBSTANCE AND REMOVED THE EXTENDED WORKING CHANNEL (EWC) ALL TOGETHER. CASE WAS COMPLETED AND THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8477789 ↗
Other System, x-ray, tomography, computed devices
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- ARTIS icono floor 11327700Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls24 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed13 recalls5 reports
- Spectral CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed11 recalls3 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, X-Ray, Tomography, Computed9 recalls20 reports
- Brilliance iCTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed8 recalls6 reports
- Revolution Apex EliteGE Medical Systems, L.L.C. · System, x-ray, tomography, computed8 recalls0 reports
- Brilliance CT Big BorePhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed7 recalls1 report
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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