Reported Jul 14, 2021 · Ongoing
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
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 R Delivery Catheter System
- REFENVEOR-L; ENVEOR-N
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 00643169800922Model Number/Description: ENVEOR-L/DELIV SYS EnVeoR-L OREVAC 18Fr — Lot Numbers: 0010199879; 0010204030; 0010209069; 0010209070; 0010279048; 0010281657; 0010289860; 0010296299 00643169800946Model Number/Description: ENVEOR-N/DELIV SYS EnVeoR-N OREVAC 20Fr — Lot Numbers 0010199873; 0010199874; 0010209064; 0010211942; 0010253924; 0010258778; 0010260161; 0010262936; 0010289861; 0010296302; 0010297110; 0010301887 - 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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