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

Recall Z-0587-2018 — Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. Evera XT VR ICD DF1 (

U.S. FDA — Device Enforcement · United States · 2017-12-19 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0587-2018
Date of alert: 2017-12-19
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00643169018044

Reported risk: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

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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