CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;

Class I - Dangerous

🏥 Medical Devices Recalled: June 11, 2021 Medtronic Heart Valves Division Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
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;
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Medtronic Heart Valves Division
Reason for Recall:: Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;

Product Codes/Lot Numbers:

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;