EV3 Inc.
FDA adverse event reports naming EV3 Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: EV3 INC..
- Total reports
- 1,591
- Deaths
- 49
- Injuries
- 1,381
- Malfunctions
- 81
Reports per year
Source: FDA adverse event reports by year received, 2003–2021. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Stents, Drains And Dilators For The Biliary DuctsFGE502
- Catheter, Peripheral, AtherectomyMCW267
- Temporary Carotid Catheter For Embolic CaptureNTE242
- Stent, CarotidNIM214
- Catheter, PercutaneousDQY182
- Catheter, EmbolectomyDXE30
- Wire, Guide, CatheterDQX26
- Stent, Superficial Femoral ArteryNIP25
- Catheter, Angioplasty, Peripheral, TransluminalLIT24
- Stent, RenalNIN24
Recent recalls
- 2016-04-22TerminatedLabeling False and Misleading
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.
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