Z-1524-2014 Class II Terminated
FDA device recall Z-1524-2014 was initiated by Medtronic Neuromodulation on Feb 27, 2014 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Nov 7, 2014). Affected quantity: 170,286 US, 73,921 OUS for all devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 7, 2014
- Initiation Date
- Feb 27, 2014
- Termination Date
- Nov 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 170,286 US, 73,921 OUS for all devices.
Product Description
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), RestorePrime (37701), PrimeAdvanced (37702), Spinal Cord Stimulators for chronic pain.
Reason for Recall
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
Distribution Pattern
Nationwide Distribution - all states including DC and Puerto Rico.
Code Information
The first released affected product was released to the market in April, 2005.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1524-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026