Changeflow GovPing Healthcare MiniMed 720G Insulin Pump Class II Recall
Priority review Enforcement Amended Final

MiniMed 720G Insulin Pump Class II Recall

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Summary

FDA announces Class II recall of Medtronic MiniMed 720G Insulin Pumps (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) due to unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site because of changes in gravitational force. All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) are affected. The recall has worldwide distribution including US nationwide.

What changed

FDA initiated a Class II recall affecting Medtronic MiniMed 720G Insulin Pumps and all related Paradigm, 600, and BLE 700 series infusion pumps. The recall addresses a defect where gravitational force changes when the pump is elevated or lowered relative to the infusion site can cause unintended over- or under-delivery of insulin. The affected products are distributed worldwide with US nationwide availability.

Healthcare providers and patients using these insulin pump models should be aware of the insulin delivery malfunction risk. Providers should identify patients with affected devices, monitor for dosing irregularities, and report any adverse events through FDA MedWatch. The recall is ongoing and manufacturers should implement corrective actions to address the gravitational force-related delivery issue.

What to do next

  1. Monitor for unintended insulin delivery patterns when pump position changes relative to infusion site
  2. Identify and contact patients using affected MiniMed pump models
  3. Report adverse events related to this recall to FDA MedWatch

Archived snapshot

Apr 14, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Medtronic MiniMed, Inc.

Device Recalls (Class II)

← All Device Recalls (Class II) Class II Z-1745-2026 · 20260408 · Ongoing

Product

MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)

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 ...

Distribution

Worldwide - US Nationwide distribution including in the states of OR, CA, AZ, NY,TX,FL, OH, MO, TN,NJ, NC, SC, IL, VA, WA, DC, GA, PA, MS,IA, MI, N...

Source: openFDA Enforcement API

Named provisions

MiniMed 720G Insulin Pump Paradigm series infusion pumps 600 series infusion pumps BLE 700 series infusion pumps

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Last updated

Classification

Agency
FDA
Filed
April 8th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1745-2026

Who this affects

Applies to
Medical device makers Healthcare providers Patients
Industry sector
3345 Medical Device Manufacturing
Activity scope
Insulin pump recall Medical device adverse event monitoring Infusion pump safety
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Pharmaceuticals Public Health Product Safety

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