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Class 2 Device Recall CoreValve Evolut PRO PLUS Delivery Catheter System |
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| Date Initiated by Firm |
June 11, 2021 |
| Create Date |
July 09, 2021 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2043-2021 |
| Recall Event ID |
88113 |
| Product Classification |
Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
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| Product |
CoreValve Evolut PRO PLUS Delivery Catheter System,
REF:
D-EVPROP2329US;
D-EVPROP34US; |
| Code Information |
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; |
Recalling Firm/
Manufacturer |
Medtronic Heart Valves Division
1851 E Deere Ave
Santa Ana CA 92705-5720
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| For Additional Information Contact |
888-2837868
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Manufacturer Reason
for Recall |
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
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FDA Determined
Cause 2 |
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 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 |
| Quantity in Commerce |
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, DOMINICAN REPUBLIC, Egypt, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, Germany, Greece, GUATEMALA, HONDURAS, Hong Kong, Hungary, ICELAND, India, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), Ireland, Israel, Italy, Japan, JORDAN, KAZAKHSTAN, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LITHUANIA, Luxembourg, MACEDONIA (THE FORMER YUGOSLAV REPUBLIC OF), Malaysia, MALTA, Mexico, MOLDOVA (REPUBLIC OF), Montenegro, Netherlands, New Zealand, Norway, OMAN, Panama, Peru, Poland, Portugal, QATAR, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, SLOVAKIA (Slovak Republic), SLOVENIA, South Africa, Spain, Sweden, Switzerland, SYRIAN ARAB REPUBLIC, Taiwan (Republic of China), THAILAND, Turkey, UNITED ARAB EMIRATES, United Kingdom, URUGUAY, UZBEKISTAN, VENEZUELA and Viet Nam. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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