Paradigm Insulin Pumps

Starting date:

April 1, 2013

Posting date:

April 26, 2013

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-28909

• Reason
• Affected products

Recalled Products

1. Paradigm 522 Insulin Pump
2. Paradigm 722 Insulin Pump
3. Paradigm Insulin Infusion Pump
4. Paradigm 554 Insulin Pump
5. Paradigm 754 Insulin Pump

Reason

Medtronic is communicating to Paradigm pump users, health care professionals and the certified pump trainers about the following three issues and proactively inform customers on how to avoid and mitigate these issues.

1. Users having experienced issues with the drive support cap of the pump: the insulin pump's drive support cap holds the pump motor in place and allows the motor's piston to press against the reservoir to deliver insulin. Some users have experienced a loose drive support cap, and in rare cases the cap may protrude from the bottom of the reservoir compartment.
2. Potential pump damage due to accidental exposure to water: as explained in the pump user guide, exposure to water may result in pump alarm, damage of the pump's internal electronics, or cause the buttons to stop working. Although it is unlikely that water damage will occur if an insulin pump is splashed or briefly dunked, it should not be immersed in water.
3. Sensor graph timeout on the VEO insulin pumps only: this information applies only to Paradigm VEO (MMT-554 and MMT-754) pump users who are also using Medtronic continuous glucose monitoring and have the low glucose suspend feature enabled. The factory default setting for sensor graph timeout is set to 2 minutes. If the sensor graph timeout is set to "none" it can prevent the auto-resume of basal delivery 2-hours after a low glucose suspend event, which can result in elevated blood glucose values. This will only happen if the pump user goes to the sensor graph screen during a low glucose suspend event, and leaves that screen displayed.

Affected products