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U.S. Department of Health and Human Services

Class 2 Device Recall Intellis Model 97755 Recharger

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  Class 2 Device Recall Intellis Model 97755 Recharger see related information
Date Initiated by Firm March 25, 2021
Create Date May 06, 2021
Recall Status1 Open3, Classified
Recall Number Z-1535-2021
Recall Event ID 87674
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators:  Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator  Intellis Model 97716 Implanted Neurostimulator.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Jeff Trauring
763-514-2000
Manufacturer Reason
for Recall		 There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
FDA Determined
Cause 2		 Under Investigation by firm
Action Beginning 25-Mar-2021, Medtronic began notifying physicians in the US and consignees OUS via mail, email, fax, and/or personal visit by Medtronic personnel. In the US, each implanting physician was sent the medical device correction letter, the patient quick guide, and the customer confirmation form. Outside the US, the medical device correction letter, the patient quick guide, and the customer confirmation form were sent to the healthcare facilities. Additionally, on an ongoing basis, the patient quick guide will be provided with each replacement recharger.
Quantity in Commerce 79,616 units
Distribution Worldwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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