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

Recall Z-2969-2018 — Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe

U.S. FDA — Device Enforcement · United States · 2018-06-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2969-2018
Date of alert: 2018-06-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Inspire Medical Systems Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10855728005434

Reported risk: Incorrect use-by date on the device registration/patient file labels.

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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