Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810)
Summary
The FDA issued a Class II for Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit u by Medtronic Neuromodulation. Reason: The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger .
Details
Source
Device Recall
External ID
Z-0293-2022
Action Date
2021-12-01
Status
Ongoing
Category
device
Product Description
Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
Lot/Code Info: UDI 00763000186265
Quantity Affected: 10,081 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.
Distribution
US Nationwide, including PR. There was government distribution but no military distribution was identified.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-04
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 132 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Neuromodulation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Neuromodulation have FDA actions?
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0293-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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