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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
- PARADIGM SURE-T INFUSION SET
- PARADIGM SILHOUETTE INFUSION SETS
- PARADIGM QUICK-SET INFUSION SETS
- MIO INFUSION SETS
- 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