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

Recall Z-1121-2017 — Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the

U.S. FDA — Device Enforcement · United States · 2017-01-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1121-2017
Date of alert: 2017-01-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Neurosurgery
Product category: device
Product type: Devices

Reported risk: Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (PL) at which the valve was set and the readings determined via an x-ray image.

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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