MiniMed 630G (2020-03-05)

Starting date:

March 5, 2020

Posting date:

April 16, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72763

Last updated: 2020-04-17

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  Reason
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  Affected products

Affected Products

MiniMed 630G

Reason

Instructions to confirm rise alerts are disabled, were incorrect on the release note. The MiniMed 630g insulin pump V4.11 insulin pump is distributed in Canada with a release note that contains recommendation from Medtronic that customers do not enable the rise alert feature. The release note also includes instructions to confirm the rise alert is disabled on the MiniMed 630g pump. The rise alerts are disabled from factory and do no directly affect insulin therapy. However, it was identified that the instructions on the release note were incorrect and users were potentially not able to confirm the rise alert is disabled.

Affected products