MiniMed 600 series (2021-10-05)

Starting date:

October 5, 2021

Posting date:

October 15, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-76665

Last updated:
2021-10-19

• 
  Reason
• 
  Affected products

Affected Products

1. MINIMED 630G
2. MINIMED 670G

Reason

Medtronic initiated a recall of Minimed™ 600 Series insulin pumps with a damaged clear retainer ring in November 2019 due to reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, this could lead to over or under delivery of insulin, which could then result in Hypoglycemia or Hyperglycemia. Severe Hypoglycemia and Hyperglycemia can be life-threatening or may result in death. Serious injuries and deaths have been reported with the use of the Minimed™ 600 series insulin pumps, but have not been directly correlated with damaged clear retainer rings based on information available to Medtronic and review with independent clinical experts. Medtronic is updating this recall to replace any Minimed™ 600 series insulin pump that has a clear retainer ring with a Minimed™ 600 series insulin pump that has the updated black retainer ring design.

 

Affected products