Medtronic MiniMed 620G Insulin Pump Recall for Motor Malfunction
Medtronic is recalling 53 MiniMed 620G insulin pumps because a motor malfunction may stop insulin delivery. The issue involves a ball bearing assembly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a malfunction results in the cessation of insulin delivery, posing a risk of harm to patients with diabetes. The agency classification is Class II, and the hazard is a risk-of-harm product where specific injury reports are not detailed in the source text.
Plain-English summary
Medtronic MiniMed Inc. is recalling 53 units of the MiniMed 620G insulin pump, Model No. MMT-1710. The recall is limited to specific serial numbers listed in the agency's records. These devices are indicated for the continuous delivery of insulin for the management of diabetes mellitus.
The recall is due to a potential malfunction in the pump drive motors. The possible cause is identified as either a lack of greasing or deficient greasing in a ball bearing assembly of the motor. If this malfunction occurs, the pump will display an error message alarm notifying the user that insulin is no longer being delivered.
The affected units were distributed internationally to Australia, Austria, Belgium, Chile, the Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, India, Ireland, Italy, Japan, Kenya, Luxembourg, Namibia, the Netherlands, Norway, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom. Users should check their pump's serial number against the provided list and contact Medtronic for instructions.
The recalled product
- Product
- MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump…
- Manufacturer
- Medtronic MiniMed Inc.
- Category
- Medical Device — Insulin Pump
- Affected units
- 53
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Medtronic MiniMed Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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