This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Paradigm Insulin Pumps and Paradigm Insulin Infusion Pump (2014-03-17)
- Starting date:
- March 17, 2014
- Posting date:
- April 14, 2014
- 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-39013
Recalled Products
A. Paradigm 522 Insulin Pump
B. Paradigm 722 Insulin Pump
C. Paradigm Insulin Infusion Pump
D. Paradigm 554 Insulin Pump
E. Paradigm 754 Insulin Pump
Reason
Purpose of this notification is to reinforce important information regarding the safe use of Medtronic insulin pumps. Medtronic has received a small number of reports regarding users who have unintentionally programmed the pump to deliver the maximum bolus amount, including one incident that resulted in severe hypoglycemia. The inadvertent selection and delivery of a bolus amount that exceeds the amount intended by the user can result in hypoglycemia.
Medtronic is notifying all Paradigm pump users Healthcare professionals and certified pump trainers of the function of the wrap around scrolling feature and make them aware of the potential for user error.
Affected products
A. Paradigm 522 Insulin Pump
Lot or serial number
All lots
Model or catalog number
MMT-522
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES
B. Paradigm 722 Insulin Pump
Lot or serial number
All lots
Model or catalog number
MMT-722
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES
C. Paradigm Insulin Infusion Pump
Lot or serial number
All lots
Model or catalog number
MMT-511
MMT-512
MMT-515
MMT-712
MMT-715
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES
D. Paradigm 554 Insulin Pump
Lot or serial number
All lots
Model or catalog number
MMT-554
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES
E. Paradigm 754 Insulin Pump
Lot or serial number
All lots
Model or catalog number
MMT-754
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES