Recall of Various Lots of Medtronic MiniMed Insulin Reservoirs
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Starting date:
July 12, 2013
Posting date:
July 12, 2013
Type of communication:
Information Update
Subcategory: Medical Device

Source of recall: Health Canada

Issue: Product Safety

Audience: General Public

Identification number: RA-34599

Issue

Medtronic of Canada Ltd., in consultation with Health Canada, is recalling select lots (see list below) of Paradigm Medtronic MiniMed Insulin Reservoirs, model # MMT-326A and MMT-332A, manufactured by Medtronic MiniMed. These insulin reservoirs are used with Paradigm insulin infusion pumps.

Medtronic is recalling these lots due to the potential risk of a leak in the reservoir that may result in under-delivery of insulin. As well, if there is an obstruction in the infusion set, the pump alarm may not be triggered. The under-delivery of insulin may cause hyperglycemia (high blood sugar), and in extreme cases may cause loss of consciousness or death.

Medtronic of Canada Ltd is notifying all customers who have purchased products from them of this recall and advising them to check their supplies to see if they have received affected lots. The lot number can be found on the side panel of the reservoir box and on the packaging of each individual reservoir.

Patients who have devices from the affected lots or who are concerned about this device should contact Medtronic of Canada Ltd.ís Diabetes Consumer Care line immediately at 1-800-284-4416 or email medtronicdiabetescc@medtronic.com. Patients who have health concerns related to their use of this device should speak with their health care professional.
Affected products Model Volume Lot Numbers Affected
MMT-326A 1.8 ml H8500423
H8500472
H8503728
H8539013
H8510440
H862775
MMT-332A 3. 0 ml H8471745
H8469703
H8473106
H8473271

H8476270
H8492449
H8492449
H8496561
H8517079


Report health or safety concerns

Complaints involving medical devices can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:

Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9