Reported Jul 14, 2021 · Ongoing
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
Medtronic Heart Valves Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Heart Valves Division · 1851 E Deere Ave · Santa Ana, CA · 92705-5720
Is this the product you have?
- CoreValve Evolut PRO PLUS Delivery Catheter System
- REF
D-EVPROP2329USD-EVPROP34US
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 00763000207854Model Number/Description: D-EVPROP2329US/DELIV SYS D-EVPROP2329US — 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 00763000207861Model Number/Description:D-EVPROP34US/DELIV SYS D-EVPROP34US SA — Lot Numbers: 0010165309; 0010165311; 0010291593; 0010294653; 0010294654; 0010303395 - Amount recalled
- Total of all Delivery Systems (Globally) = 67,339 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Heart Valves Division recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.