Reported Dec 16, 2020 · Terminated
Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN,…
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?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US |
| 2 | EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US |
| 3 | EVPROPLUS-29US, Labeled as VLV EVPROPLUS-29US COMM JPN, VLV EVPROPLUS-29 COMM US |
| 4 | EVPROPLUS-34US, Labeled as VLV EVPROPLUS-34 COMM US, VLV EVPROPLUS-34 COMM US SA. |
- Lot codes and dates
- All GTINs and associated serial numbers (refer to Attachment A-Product List as of 22-Oct-2020).
- Amount recalled
- 19,961 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
- Nationwide
Why it was recalled
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
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.
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