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

Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNAP REG 120CM, 27812 - VALVE 27812 STRATA II SM EXTRACTED, 27814 - SHUNT 27814 STRATA II ASSY SML — recall Z-1116-2021

U.S. FDA — Device Enforcement · United States · 2021-01-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1116-2021
Date of alert: 2021-01-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Neurosurgery
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0219498492

Reported risk: Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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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