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Medtronic Heart Valves Division recalls Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM J
Recalled December 16, 2020 · FDA recall Z-0561-2021 · Medtronic Heart Valves Division
Hazard
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID). · FDA Class II
Units
19,961 units
Sold at
Worldwide distribution - U.S. Nationwide distribution and the countries of Panama, Denmark, Austria, Germany, Finland, Sweden, Colombia, India, Mexico, Brazil, Spain, United Kingdom, Australia, Ireland, Italy, Argentina, Japan, Poland, Russian Federation, Hungary, Kazakhstan, Luxembourg, Portugal, Norway, Egypt, Saudi Arabia.
Description
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Product
Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV EVPROPLUS-29US COMM JPN, VLV EVPROPLUS-29 COMM US; d. EVPROPLUS-34US, Labeled as VLV EVPROPLUS-34 COMM US, VLV EVPROPLUS-34 COMM US SA.
Manufacturer(s)
Medtronic Heart Valves Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →