Recall Z-2043-2021
Medtronic Heart Valves Division · initiated June 11, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
Codes / lots: 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;
Reason for recall
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
FDA-determined cause: Device Design
Action taken
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 inventory to Recalling Firm. Contact Customer Service at 800-854-3570 to initiate a product return. Their local Representative can assist them as necessary in initiating the return of this product. 3. Complete the enclosed Customer Confirmation Form and email it to rs.cfqfca@medtronic.com. 4. Forward this notice to all who need to be aware within their organization and to any organization where the affected product may have been transferred. For any questions or assistance, contact Customer Service at 800-854-3570
Details
- Recall number
- Z-2043-2021
- Initiated
- June 11, 2021
- Product code
- NPT – Aortic Valve, Prosthesis, Percutaneously Delivered
- 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, Canada, Chile, CHINA, Colombia, COSTA RICA, Croatia, Curacao, CYPRUS, Czech Republic, Denmark…
- Recalling firm
- Medtronic Heart Valves Division, Santa Ana, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2041-2021 Class II | CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;Due to reports of actuator separation for various delivery catheter systems. Affected products were… | 06/11/2021Open, Classified |
| Z-2042-2021 Class II | CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;Due to reports of actuator separation for various delivery catheter systems. Affected products were… | 06/11/2021Open, Classified |