CLASS II ONGOING Device recall · Reported 1 Dec 2021 · FDA Enforcement Report
Medtronic Wireless Recharger recalled by Medtronic Neuromodulation
Medtronic Neuromodulation is recalling Medtronic Wireless Recharger, distributed nationwide in the US. The recall was initiated on 4 Nov 2021 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-0295-2022
- FDA event ID
- 88953
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Nov 2021
- FDA classified
- 24 Nov 2021
- Reported
- 1 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 4 Nov 2021 | Recall initiated by company | |
| 24 Nov 2021 | Classified by FDA | +20 days |
| 1 Dec 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.
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 Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI (Model 97714) implantable neurostimulators.
Where it was distributed
US Nationwide, including PR. There was government distribution but no military distribution was identified.
Questions about this recall
Is Medtronic Wireless Recharger recalled?
Yes. Medtronic Neuromodulation recalled Medtronic Wireless Recharger on 4 Nov 2021. The recall is Class II and its status is Ongoing. Recall number Z-0295-2022.
Why was it recalled?
The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.
Which lots are affected?
UDI 00763000217921
Where was it sold?
US Nationwide, including PR. There was government distribution but no military distribution was identified.
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
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