Paradigm Insulin Infusion Pump and MMT-508, Paradigm 522, Paradigm 722, Paradigm 554, and Paradigm 754 Infusion Pumps (2019-06-27)
- Starting date:
- June 27, 2019
- Posting date:
- July 5, 2019
- 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-70351
Last updated: 2019-07-05
Affected Products
- MMT-508 Insulin Pump
- Paradigm 522 Insulin Pump
- Paradigm 722 Insulin Pump
- Paradigm Insulin Infusion Pump
- Paradigm Insulin Infusion Pump
- Paradigm 554 Insulin Pump
- Paradigm 754 Insulin Pump
Reason
Medtronic is making customers aware of a potential cybersecurity risk. Security researchers have identified potential cybersecurity vulnerabilities related to the listed insulin pumps. An unauthorized person with special technical skills and equipment could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery. This could lead to hypoglycemia (if additional insulin is delivered) or hyperglycemia and diabetic ketoacidosis (if not enough insulin is delivered). At this time, Medtronic has received no confirmed reports of unauthorized persons changing settings or controlling insulin delivery.
Affected products
A. MMT-508 Insulin Pump
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MMT-508
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES
B. Paradigm 522 Insulin Pump
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MMT-522
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES
C. Paradigm 722 Insulin Pump
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MMT-722
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES
D. Paradigm Insulin Infusion Pump
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MMT-511
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES
E. Paradigm Insulin Infusion Pump
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- MMT-512
- MMT-515
- MMT-712
- MMT-715
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES
F. Paradigm 554 Insulin Pump
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- MMT-554
- MMT-554CMB
- MMT-554CMH
- MMT-554CML
- MMT-554CMP
- MMT-554CMS
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES
G. Paradigm 754 Insulin Pump
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- MMT-754
- MMT-754CMB
- MMT-754CMH
- MMT-754CML
- MMT-754LCMS
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES