Medtronic Heart Valves Division recalls CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L
Recalled Product
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
Hazard / Issue
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Issued by
FDA
Affected States: AL, AK, AR, AZ, CA, CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV
Lot/Code Info: Model Number/Description: ENVEOR-L/DELIV SYS EnVeoR-L OREVAC 18Fr GTIN: 00643169800922 Lot Numbers: 0010199879; 0010204030; 0010209069; 0010209070; 0010279048; 0010281657; 0010289860; 0010296299; Model Number/Description: ENVEOR-N/DELIV SYS EnVeoR-N OREVAC 20Fr GTIN: 00643169800946 Lot Numbers 0010199873; 0010199874; 0010209064; 0010211942; 0010253924; 0010258778; 0010260161; 0010262936; 0010289861; 0010296302; 0010297110; 0010301887;
View official government recall
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