Medtronic Recalls MiniMed 620G Insulin Pumps Due to Keypad Malfunction
Medtronic is recalling 6,573 MiniMed 620G insulin infusion pumps because the keypad may become unresponsive and the pump may become temporarily stuck.
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 (insulin pump) where a malfunction (unresponsive keypad/stuck pump) poses a risk of harm to the user, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic Inc. is recalling 6,573 units of the MiniMed 620G Insulin Infusion Pump (Catalog Nos. MMT-1510, MMT-1710, MMT-1550, MMT-1750). The recall is being conducted because the device may become temporarily stuck and the keypad may 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. Specific serial numbers for the affected units are listed in the official recall documentation.
Consumers using these devices should contact Medtronic for further instructions on how to address the malfunction. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Insulin Pump
- Affected units
- 6,573
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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