CLASS II Device recall · Reported 7 May 2014 · FDA Enforcement Report
Medtronic, External neurostimulator, ENS (37021) & ENS (37022) recalled
Medtronic Neuromodulation is recalling Medtronic, External neurostimulator, ENS (37021) & ENS (37022), distributed nationwide in the US. The recall was initiated on 27 Feb 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1526-2014
- FDA event ID
- 66841
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Feb 2014
- FDA classified
- 29 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 27 Feb 2014 | Recall initiated by company | |
| 29 Apr 2014 | Classified by FDA | +61 days |
| 7 May 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators which are associated with software application run on the NVision Clinician Programmer and used during trialing for spinal cord stimulation (SCS) patients.
Where it was distributed
Nationwide Distribution - all states including DC and Puerto Rico.
Questions about this recall
Is Medtronic, External neurostimulator, ENS (37021) & ENS (37022) recalled?
Yes. Medtronic Neuromodulation recalled Medtronic, External neurostimulator, ENS (37021) & ENS (37022) on 27 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-1526-2014.
Why was it recalled?
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
Which lots are affected?
The first released affected product was released to the market in April, 2005.
Where was it sold?
Nationwide Distribution - all states including DC and Puerto Rico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Neuromodulation
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medtronic Pocket Adaptor Kit for Deep Brain Stimulation recalled | Medtronic Neuromodulation | Other | Nationwide |
| Device | CLASS II | Medtronic Pocket Adaptor Kit for Deep Brain Stimulation recalled | Medtronic Neuromodulation | Other | Nationwide |
| Device | CLASS II | A71200 Vanta" Clinician Programmer Application (CP App) recalled | Medtronic Neuromodulation | Device Malfunction | Nationwide |
| Device | CLASS II | Restore Clinician Programmer Application (CP App) recalled | Medtronic Neuromodulation | Device Malfunction | Nationwide |
| Device | CLASS II | Enhanced Verify Evaluation Handset (CFN HH90130FA) recalled | Medtronic Neuromodulation | Device Malfunction | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |