Medtronic MiniMed 640G Insulin Pumps Recalled for Motor Malfunction
Medtronic MiniMed is recalling 1,052 MiniMed 640G insulin pumps due to a potential drive motor malfunction that could stop insulin delivery.
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 for insulin delivery where a malfunction could result in the cessation of insulin, posing a risk of harm to patients with diabetes, but no injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic MiniMed Inc. is recalling 1,052 units of the MiniMed 640G insulin pump system, specifically models MMT-1711 and MMT-1712. The recall involves the 3.0mL mmol/L and 3.0mL mg/dL configurations. These devices are indicated for the continuous delivery of insulin and continuous monitoring of glucose levels for the management of diabetes mellitus.
The recall is being issued because the pump drive motors may experience a malfunction resulting in a pump error message alarm that notifies the user that insulin is no longer being delivered. The possible cause of this malfunction is identified as either a lack of greasing or deficient greasing in a ball bearing assembly of the motor.
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. The source text does not specify instructions for consumers or report any illnesses or injuries associated with this recall.
The recalled product
- Product
- MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 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…
- Manufacturer
- Medtronic MiniMed Inc.
- Category
- Medical Device — Insulin Pump
- Affected units
- 1,052
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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