Health product recall

Paradigm Insulin Infusion Pumps Remote Programmer (2018-08-13)

Starting date:
August 13, 2018
Posting date:
September 7, 2018
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-67684

Affected products

Paradigm Insulin Infusion Pumps Remote Programmer

Reason

An external security researcher has identified a potential vulnerability related to the MiniMed Paradigm Family of insulin pumps and corresponding remote controller. The researcher's report states that an unauthorized individual in close proximity of an insulin pump user could potentially copy the wireless Radio Frequency (RF) signals from the user's remote controller (while they are in the process of delivering a remote bolus) and play those back later to deliver an involuntary bolus of insulin to the user. This could lead to potential health risks such as hypoglycemia if additional insulin is delivered beyond the user's insulin requirements.

Affected products

Paradigm Insulin Infusion Pumps Remote Programmer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • MMT-503
  • MMT-503NA
Companies
Manufacturer

MEDTRONIC MINIMED

18000 DEVONSHIRE ST

NORTHRIDGE

91325

California

UNITED STATES