Paradigm Insulin Pump (MMT-712, MMT-715)
Pending LLM rewrite. Source: FDA_DEVICE Z-1748-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
The recalled product
- Product
- Paradigm Insulin Pump (MMT-712, MMT-715)
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Devices
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)
- 643169729360
- 763000065201
- 763000069001
- 763000192228
- 763000198602
- 763000155346
- 763000192143
- 763000258344
- 763000317140
- 763000404567
- 763000317188
- 763000317195
- 763000367046
- 763000317157
- 00613994470492
- 00643169496262
- 643169577664
- 643169577688
- 643169577695
- 643169739512
Distribution
Distributed nationwide across the United States.
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