FDA-Device2016-05-04Class II
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
ev3, Inc.
Hazard
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.
Sold states
US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
Affected count
27 (25 US, 2 OUS)
Manufactured in
3033 Campus Drive, N/A, Minneapolis, MN, United States
Products
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1552-2016Don't want to check this manually?
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