CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
Check against the official notice below — it lists the full affected range.
Medtronic is recalling CoreValve Evolut R Delivery Catheter System models ENVEOR-L and ENVEOR-N due to reports of actuator separation. The affected products were manufactured before July 11, 2020, and distributed across the United States, Puerto Rico, and numerous countries internationally. A total of 67,339 units were affected globally, with specific lot numbers identified for both the ENVEOR-L (18Fr) and ENVEOR-N (20Fr) models.
The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Reason for recall: Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020. Distribution: U.S.: 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, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Albania, Argentina, Australia, Austria, Belarus, Belgium, Brazil, BULGARIA, Canada, Chile, CHINA, Colombia, COSTA RICA, Croatia, Curacao, CYPRUS, Czech Republic, Denmark, DOMINICAN Quantity: Total of all Delivery Systems (Globally) = 67,339 units 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;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.