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

Recall Z-0124-2014 — Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable p

U.S. FDA — Device Enforcement · United States · 2013-09-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0124-2014
Date of alert: 2013-09-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Neuromodulation
Product category: device
Product type: Devices

Reported risk: Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended.

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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