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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Product Description
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FDA Recall
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Z-0560-2021 - Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 BLUE COMM JPN, VLV ... 2 12/10/2020 Medtronic Heart Valves Division
Z-0561-2021 - 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-2... 2 12/10/2020 Medtronic Heart Valves Division
Z-0559-2021 - Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVO... 2 12/10/2020 Medtronic Heart Valves Division
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