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

Recall Z-1524-2014 — Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703), Itrel 4 (37704), Resto

U.S. FDA — Device Enforcement · United States · 2014-02-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1524-2014
Date of alert
2014-02-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Neuromodulation
Product category
device
Product type
Devices
Reported risk: Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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