Medtronic Recalls MiniMed 640G Insulin Pumps Due to Keypad Malfunction
Medtronic is recalling 117,239 MiniMed 640G insulin pumps because the keypad may become unresponsive, potentially preventing users from adjusting 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 is classified as FDA Class II. The hazard involves a critical medical device (insulin pump) becoming unresponsive, which poses a risk of harm to users, but the source text does not report any specific injuries or hospitalizations, placing it in the 'High' category rather than 'Severe'.
Plain-English summary
Medtronic Inc. is recalling 117,239 units of the MiniMed 640G Insulin Infusion Pump (Catalog Nos. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752). The recall was initiated because the device may become temporarily stuck, causing the keypad to become unresponsive.
The affected pumps were distributed in the United States and numerous countries outside the US, including Australia, Canada, and various nations in Europe, Asia, and the Middle East. The source text does not specify the number of reported illnesses or injuries associated with this defect.
Consumers using these specific serial numbers should contact Medtronic for instructions on how to proceed. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752.
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Insulin Pump
- Affected units
- 117,239
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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