Edge SD90EWCTE-FTRecalls & reported problems
Covidien LP · FirmTip;Extended Working Channel;90 Catheter · Class 2
All models of Edge (43)
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 10884521199590), received between Nov 27, 2024 and Nov 27, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Pneumothorax1
- Respiratory Failure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED THE DIAGNOSTIC YIELD OF ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) AND SHAPE-SENSING ROBOTIC-ASSISTED BRONCHOSCOPY (SSRAB)-GUIDED CONE-BEAM COMPUTED TOMOGRAPHY CBCT. A TOTAL OF 92 PATIENTS UNDERWENT ENB-CBCT AND 93 PATIENTS UNDERWENT SSRAB-CBCT FOR BIOPSY OF PULMONARY NODULES BETWEEN JULY 2020 AND MAY 2023. SUPERDIMENSION WAS USED IN THE ENB GROUP WITH AN EXTENDED WORKING CHANNEL CATHETER. THE NEEDLE OR A COMPETITOR DEVICE WAS USED FOR FINE NEEDLE ASPIRATION, FOLLOWED BY A COMPETITOR BIOPSY FORCEPS AND CYTOLOGY BRUSH TO ACQUIRE TISSUE. ALL PATIENTS UNDERWENT ENDOBRONCHIAL ULTRASOUND (EBUS)-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION FOR MEDIASTINAL STAGING FOLLOWING NAVIGATIONAL BRONCHOSCOPY. COMPLICATIONS INCLUDED: PNEUMOTHORAX IN 2(2.1%) PATIENTS, ONE PATIENT HAD HYPOXIC RESPIRATORY FAILURE AND TWO (2.1%) PATIENTS HAD HEMODYNAMIC INSTABILITY. INTERVENTIONS WERE NOT REPORTED. CONE-BEAM COMPUTED TOMOGRAPHY-GUIDED SHAPE-SENSING ROBOTIC BRONCHOSCOPY VS. ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY FOR PULMONARY NODULES 10.21037/JTD-24-178.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pneumothorax; Respiratory Failure
MAUDE report 20801238 ↗
Other System, x-ray, tomography, computed devices
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- 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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