MiniMed Insulin Pumps Recalled for Battery Failure After Physical Impact
MiniMed insulin pumps are recalled because physical impact can damage internal components, reduce battery life, and cause unexpected device shutdown that interrupts 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: FDA Class I classification establishes minimum severity of 4. The defect poses significant risk of harm: unexpected device shutdown interrupts insulin delivery, potentially resulting in hyperglycemia or diabetic ketoacidosis. However, no deaths or documented injuries are reported in the source, preventing a Critical rating.
Plain-English summary
Medtronic MiniMed, Inc. is recalling 234,360 units of MiniMed insulin pumps, including models 620G, 630G, 640G, 720G, and 740G. These pumps have been distributed throughout the United States and internationally.
These pumps can be damaged if dropped, bumped, or experience physical impact. When physical damage occurs, it can harm internal electrical components, reducing the battery's ability to hold a charge. The damaged battery causes the pump's low battery alarm to activate much later than designed—potentially only about 2.5 hours before the device shuts down completely, or even sooner based on patient reports. Replacing the battery will not resolve this issue because the internal damage persists.
When a damaged pump's battery runs out, the device stops delivering insulin without warning. Interrupted insulin delivery can result in insufficient insulin reaching the patient, potentially causing hyperglycemia (dangerously high blood sugar) or diabetic ketoacidosis (DKA). Patients with any of the affected pump models should inspect their device for signs of physical damage. Anyone who has dropped or impacted their pump should contact Medtronic immediately.
The recalled product
- Product
- MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G Insulin Pump, REF…
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Insulin Pump
- Affected units
- 234,360
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI(GTIN): MMT-1710/00643169568419
- MMT-1750/00763000253189
- 00763000375461
- 00643169721319
- 00643169559745
- 763000253189
- MMT-1714/00763000253059
- 00763000074845
- 00643169782396
- 763000253059
- 643169782396
- MMT-1715/ 00763000316631
- 763000190439
- 763000316631
- MMT-1754/00763000253066
- 00643169976344
- 00763000315719
- 00763000381912
- 763000253066
- MMT-1755/643169752726
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medtronic MiniMed, 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.
See all 3 products in this recall →Related recalls
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