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

Recall Z-3020-2017 — VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 1

U.S. FDA — Device Enforcement · United States · 2017-06-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3020-2017
Date of alert: 2017-06-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cyberonics, Inc
Product category: device
Product type: Devices

Reported risk: Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.

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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