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

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  Reason
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  Affected products

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