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

Recall Z-1117-2021 — Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L 22011 M - SHUNT 22011 M INTL ONLY ULTRA SM MED 22017 B-L - SHUNT 22017 B-L ASSY US PER 90CM SM LOW 22017

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-1117-2021
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): 0219278853

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.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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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