CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
Check against the official notice below — it lists the full affected range.
Medtronic is recalling CoreValve Evolut PRO PLUS Delivery Catheter Systems (model numbers D-EVPROP2329US and D-EVPROP34US) due to reports of actuator separation in the delivery catheter systems. The affected products were manufactured before July 11, 2020, and a total of 67,339 units were distributed globally, including throughout the United States, Puerto Rico, and numerous countries internationally.
The recall involves specific lot numbers for both model variants. The source document does not specify a remedy or recommended course of action 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: D-EVPROP2329US/DELIV SYS D-EVPROP2329US GTIN:00763000207854 Lot Numbers: 0010165308; 0010165310; 0010165312; 0010165313; 0010169462; 0010169464; 0010171866; 0010171868; 0010171869; 0010173361; 0010175293; 0010175294; 0010181410; 0010181411; 0010181412; 0010182735; 0010182736; 0010188541; 0010192246; 0010192247; 0010197788; 0010197790; 0010199877; 0010199878; 0010199880; 0010204029; 0010216175; 0010216176; 0010222009; 0010222011; 0010225047; 0010271291; 0010271292; 0010271293; 0010273071; 0010279050; 0010279938; 0010288574; 0010289862; 0010291595; 0010291597; 0010294650; 0010294651; 0010294652; 0010296300; 0010296301; Model Number/Description:D-EVPROP34US/DELIV SYS D-EVPROP34US SA GTIN:00763000207861 Lot Numbers: 0010165309; 0010165311; 0010291593; 0010294653; 0010294654; 0010303395;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.