Medtronic Recalls MiniMed 630G Insulin Pumps Due to Keypad Malfunction
Medtronic is recalling 65,959 MiniMed 630G insulin pumps because the device may become temporarily stuck and the keypad may become unresponsive.
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 is classified as FDA Class II, and the hazard involves a critical medical device (insulin pump) malfunctioning, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Medtronic Inc. is recalling the MiniMed 630G Insulin Infusion Pump (Catalog No. MMT-1715, MMT-1755) under FDA recall number Z-2603-2017. The recall involves 65,959 units distributed in the United States and numerous international locations.
The recall was initiated because the insulin pump may become temporarily stuck, causing the keypad to become unresponsive. This malfunction could interfere with the user's ability to operate the device.
Consumers with affected serial numbers should contact Medtronic for instructions on how to proceed. The specific serial numbers for the affected units are listed in the official FDA recall documentation.
The recalled product
- Product
- MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Insulin Pump
- Affected units
- 65,959
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Medtronic 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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