Has Medtronic MiniMed, Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 37 total FDA actions tied to Medtronic MiniMed, Inc., including 37 recalls and 0 warning letters.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

FDA Recall Database: Class II Recall: Paradigm Insulin Pump (MMT-712, MMT-715) by Medtronic MiniMed, Inc.

Here's the summary: FDA classified a recall by Medtronic MiniMed, Inc. as Class II, reported 20260408. The affected product is Paradigm Insulin Pump (MMT-712, MMT-715) (recall number Z-1748-2026). Reason for recall: 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.. Status: Ongoing.

Key facts

Recalling firm	Medtronic MiniMed, Inc.
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Paradigm Insulin Pump (MMT-712, MMT-715)
Classification	Class II
Recall number	Z-1748-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	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.

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of Paradigm Insulin Pump (MMT-712, MMT-715) should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Medtronic MiniMed, Inc.. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Medtronic MiniMed, Inc. should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Medtronic MiniMed, Inc. directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Medtronic MiniMed, Inc.’s FDA history

Argus HQ has recorded 37 total FDA actions tied to Medtronic MiniMed, Inc.: 0 warning letters, 37 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has Medtronic MiniMed, Inc. had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 37 total FDA actions tied to Medtronic MiniMed, Inc., including 37 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-1748-2026.
What is the current status of this recall?: Status as recorded by FDA: Ongoing.
Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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Full FDA history for Medtronic MiniMed, Inc.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Recall Database: Class II Recall: Paradigm Insulin Pump (MMT-712, MMT-715) by Medtronic MiniMed, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/medtronic-minimed-z-1748-2026-2026-04-08

MLA

"FDA Recall Database: Class II Recall: Paradigm Insulin Pump (MMT-712, MMT-715) by Medtronic MiniMed, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/medtronic-minimed-z-1748-2026-2026-04-08.

Chicago

Argus HQ Research. "FDA Recall Database: Class II Recall: Paradigm Insulin Pump (MMT-712, MMT-715) by Medtronic MiniMed, Inc.." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/recall/medtronic-minimed-z-1748-2026-2026-04-08.

BibTeX

@misc{argushq_argushq_ai_recall_medtronic_minimed_z_1748_2026_2026_04_08_2026,
  title = {FDA Recall Database: Class II Recall: Paradigm Insulin Pump (MMT-712, MMT-715) by Medtronic MiniMed, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/medtronic-minimed-z-1748-2026-2026-04-08},
  note = {Accessed: July 17, 2026}
}

Source: FDA.gov — Recalls ↗