Recall Z-2043-2021 ยท NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Medtronic Heart Valves Division
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
| Date | Jun 11, 2021 |
| Status | Open, Classified |
| Reason | Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020. |
| Root cause | Device Design |
| Action | On 06/09/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE RECALL" Notification via UPS 2-day (US Customers) and regionally approved methods (OUS Customer) to customers informing them that it has been identified that were is the potential for actuator separation with delivery catheter systems manufactured before 07/11/2020. Customer are instructed to: 1. Identify and quarantine all unused affected product manufactured before 11-JUL-2020.The enclosed Customer Notification Detail Report includes affected product for their facility. 2. Return all unused affected product in their inventor |
| Quantity | Total of all Delivery Systems (Globally) = 67,339 units |
| 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, Cana |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.