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Health product recall

Medtronic (Unomedical) Infusion Sets (2017-09-11)

Starting date:
September 11, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-64526

Affected products

  1. PARADIGM SURE-T INFUSION SET
  2. PARADIGM SILHOUETTE INFUSION SETS
  3. PARADIGM QUICK-SET INFUSION SETS
  4. MIO INFUSION SETS
  5. MINIMED MIO 30

Reason

Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. The reported incidence rate requiring medical assistance related to this issue is less than 1 in every 2 million infusion sets. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue.

Manufacturer investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid may occur if insulin, alcohol, or water is spilled on top of the insulin reservoir, which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk.

Affected products

A. PARADIGM SURE-T INFUSION SET

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • MMT-862
  • MMT-864
  • MMT-866
  • MMT-874
Companies
Manufacturer
Unomedical A/S
Aaholmvej 1-3
Osted
DENMARK

B. PARADIGM SILHOUETTE INFUSION SETS

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

MMT-368600
MMT-377600
MMT-378600
MMT-381600
MMT-382600
MMT-383600
MMT-384600

Companies
Manufacturer
Unomedical A/S
Aaholmvej 1-3
Osted
DENMARK

C. PARADIGM QUICK-SET INFUSION SETS

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

MMT-386600
MMT-387600
MMT-394600
MMT-396600
MMT-397600
MMT-398600
MMT-399600
 

Companies
Manufacturer
Unomedical A/S
Aaholmvej 1-3
Osted
DENMARK

D. MIO INFUSION SETS

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

MMT-921600
MMT-923600
MMT-941600
MMT-943600
MMT-965600
MMT-975600

Companies
Manufacturer
Unomedical A/S
Aaholmvej 1-3
Osted
DENMARK

E. MINIMED MIO 30

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

MMT-905600
MMT-905T
MMT-906600
 

Companies
Manufacturer
Unomedical A/S
Aaholmvej 1-3
Osted
DENMARK