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Open, Classified

Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.

FDA Recall Z-0293-2022 · Posted None

Recalling FirmMedtronic Neuromodulation
Recall StatusOpen, Classified
Product CodeEZW
Date Initiated2021-11-04
Product Quantity10,081 devices

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.

Firm 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.

Root Cause

Other

Distribution Pattern

US Nationwide, including PR. There was government distribution but no military distribution was identified.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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