CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
FDA Device Recall #Z-2043-2021 — Class II — June 11, 2021
Recall Summary
| Recall Number | Z-2043-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 11, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Heart Valves Division |
| Location | Santa Ana, CA |
| Product Type | Devices |
| Quantity | Total of all Delivery Systems (Globally) = 67,339 units |
Product Description
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
Reason for Recall
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Distribution Pattern
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.
Lot / 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;
Other Recalls from Medtronic Heart Valves Division
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2042-2021 | Class II | CoreValve Evolut PRO Delivery Catheter System, ... | Jun 11, 2021 |
| Z-2041-2021 | Class II | CoreValve Evolut R Delivery Catheter System, R... | Jun 11, 2021 |
| Z-0560-2021 | Class II | Evolut (TM) PRO System. With the following mod... | Oct 23, 2020 |
| Z-0561-2021 | Class II | Evolut (TM) PRO+ System. With the following mo... | Oct 23, 2020 |
| Z-0559-2021 | Class II | Evolut (TM) R System. With the following model... | Oct 23, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.