Health product recall

Enlite & Guardian Sensor (2021-03-08)

Starting date:
March 8, 2021
Posting date:
April 8, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Hospitals, Healthcare Professionals, General Public
Identification number:
RA-75331



Last updated:
2021-04-08

Affected Products 

A. Enlite Sensor

B. GUARDIAN SENSOR (3)

Reason

Medtronic is notifying all customers who may be using an Enhanced Enlite Sensor or a Guardian Sensor (3) in a Continuous Glucose Monitoring (CGM) system or in a sensor-enabled pump system that, if they are actively taking a medication that lists Hydroxyurea as its main or one of its main ingredients, their sensor could present inaccurately elevated Sensor Glucose (SG) readings. Hydroxyurea use results in higher SG readings compared to Blood Glucose (BG) readings and may result in the following: Hypoglycemia caused by over-administration of insulin. Inaccurate graphs or missed alarms and alerts. Delay to or loss of sensor-enabled insulin suspension (sensor-enabled insulin pump use only). SG readings in CareLink reports being substantially higher than BG readings.

Affected products

A. Enlite Sensor

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

MMT-7008A

Companies
Manufacturer

Medtronic Minimed

18000 Devonshire St.

Northridge

91325

California

UNITED STATES


B. GUARDIAN SENSOR (3)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

MMT-7020C4

MMT-7020D4

Companies
Manufacturer

Medtronic Minimed

18000 Devonshire St.

Northridge

91325

California

UNITED STATES