FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: 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.
- Recall number
- Z-1535-2021
- Recalling firm
- Medtronic Neuromodulation
- 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.
- Status
- Open, Classified
- Initiated
- 2021-03-25
- Posted
- not on file
- Terminated
- not on file
- Reason
- There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
- Root cause
- 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
- 79,616 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LGW
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28