Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV EVPROPLUS-29US COMM J

U.S. FDA — Device Enforcement · United States · 2020-10-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0561-2021
Date of alert: 2020-10-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Heart Valves Division
Product category: device
Product type: Devices

Reported risk: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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