Intellis Recharger (2021-03-30)
- Starting date:
- March 30, 2021
- Posting date:
- April 29, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-75483
Last updated:
2021-04-29
Affected Products
Intellis Recharger
Reason
Medtronic has become aware of an issue that may cause unintended increased heating, specifically due to damage at the location where the cable enters the recharger antenna. Due to this damage causing unintended increased heating, patients have reported experiencing temporary discomfort (e.g. heating, burning, or shocking sensations) from the recharger or signs of heating on the skin, such as redness, blistering, or a burn resulting from prolonged exposure to heat.
Affected products
Intellis Recharger
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
97755
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES