Medtronic MiniMed Insulin Pumps Recalled for Missing Audio Alerts
Medtronic is recalling specific MiniMed insulin pump models because software version 4.10 may fail to play expected audio sounds during alerts, alarms, or sirens.
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 risk-of-harm product (insulin pump) where the failure to provide audio alerts could lead to missed high or low glucose notifications, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Inc. is recalling specific units of the Medtronic MiniMed 630G, 670G, and 640G (International) insulin pumps. The recall involves 142,889 units distributed across all 50 U.S. states, the District of Columbia, Puerto Rico, and the Virgin Islands.
The recall is due to reports that insulin pumps running version 4.10 software have failed to make expected audio sounds during alerts, alarms, or sirens. This malfunction could cause users to miss system notifications, alarms, or sirens associated with the pump's operation and high or low glucose alerts.
Consumers should check their pump's software version and serial number against the recall list. If the device is affected, users should contact Medtronic for instructions on how to proceed, as missing audio alerts may impact the ability to monitor glucose levels and pump status.
The recalled product
- Product
- Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Insulin Pump
- Affected units
- 142,889
Distribution
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