Z-1535-2021 Class II Ongoing
FDA device recall Z-1535-2021 was initiated by Medtronic Neuromodulation on Mar 25, 2021 and is designated Class II. Reason for recall: There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger. The recall status is ongoing. Affected quantity: 79,616 units.
Recall details
- Product Type
- Devices
- Report Date
- May 12, 2021
- Initiation Date
- Mar 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 79,616 units
Product description
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.
Reason for recall
There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
Distribution pattern
Worldwide distribution.
Code information
All serial numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1535-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026