Medtronic MiniMed 620G Insulin Pump Recall for Loose Reservoirs
Medtronic is recalling MiniMed 620G insulin pumps not distributed in the US due to a loose reservoir that may cause incorrect insulin delivery.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly…"
Plain-English summary
Medtronic Inc. is recalling the MiniMed 620G Insulin Infusion Pump (models MMT-1510, MMT-1710, and MMT-1750) due to reported incidents of a loose reservoir. The recall applies to devices with a broken or missing retainer ring that prevents the reservoir from locking properly into the pump. The source text explicitly states that these specific units were not distributed within the United States, though the distribution pattern lists various international locations.
If the reservoir is not properly locked, it can lead to over or under delivery of insulin. This malfunction may result in hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) for the user. The recall covers all serial numbers excluding devices with black retainer rings.
Consumers should check their device for a broken or missing retainer ring. If the reservoir cannot be locked securely, the device should not be used. Users should contact Medtronic for further instructions on replacement or repair.
The recalled product
- Product
- Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Insulin Pump
Distribution
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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