Z-0295-2022Class II

Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra...

Name: Z-0295-2022 Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra...
Creator: Medtronic Neuromodulation
Published: 2021-11-04
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2021-11-04 / Open, Classified

FDA source

Medtronic Neuromodulation began a recall of Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore... on 2021-11-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0295-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-04
Posted: 2021-11-24
Recalling firm: Medtronic Neuromodulation
Product: 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.
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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.
FDA root cause: Other
Action: The recalling firm issued undated letters on 11/4/2021 via USPS Priority Shipping. The recalling firm has three different letters addressed to the Healthcare Professional depending upon the type of device the wireless recharger is used with (InterStim Micro, product number RS5200; Activa RC, product number RS6200; or RestoreUltra & RestoreSensor, Product number RS7200, which is currently not distributed in the U.S. at this time). The letter gives an issue overview and provides requested actions. Those actions include reinforcing the instructions in the enclosed Patient Quick User Guide with their patients and to attempt to reset the WR if the device appears unresponsive. If the problem is not resolved, then contact information is provided for Medtronic Technical Services. A customer confirmation form dated November 2021 was enclosed to acknowledge the consignee has received the letter.
Quantity in commerce: 10 devices
Distribution: US Nationwide, including PR. There was government distribution but no military distribution was identified.
Product codes and lots: UDI 00763000217921

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0295-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0293-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0294-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0295-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-24

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)