Changeflow GovPing Healthcare Medtronic MiniMed Insulin Pump Recall - Paradig...
Urgent Enforcement Amended Final

Medtronic MiniMed Insulin Pump Recall - Paradigm Veo Z-1752-2026

Favicon for changeflow.com FDA: Device Recalls Class II
Filed
Detected
Email

Summary

Medtronic MiniMed, Inc. is recalling Paradigm REAL-Time Veo Insulin Pumps (MMT-554, MMT-754) and all Paradigm series, 600 series, and BLE 700 series infusion pumps due to unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site because of gravitational force changes. The FDA has classified this as a Class II recall affecting devices distributed worldwide including US nationwide.

What changed

Medtronic MiniMed, Inc. initiated a Class II medical device recall affecting Paradigm REAL-Time Veo Insulin Pumps (MMT-554, MMT-754) and all Paradigm series, 600 series, 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 cause unintended over- and under-delivery of insulin, posing moderate-severity health risks to diabetic patients.\n\nHealthcare providers and patients managing diabetes should immediately identify any affected Medtronic MiniMed insulin pump models in use and coordinate with the manufacturer for replacement or correction options. Medtronic must implement the recall per FDA Class II procedures and notify affected parties of the insulin delivery malfunction and associated health risks.

What to do next

  1. Patients using affected pumps should contact healthcare provider to discuss individual risk and management options
  2. Manufacturers must follow FDA recall procedures for Class II medical device correction
  3. Monitor for updates from Medtronic regarding replacement or correction options

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-1752-2026 · 20260408 · Ongoing

Product

Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)

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

Get daily alerts for FDA: Device Recalls Class II

Daily digest delivered to your inbox.

Free. Unsubscribe anytime.

About this page

What is GovPing?

Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission

What's from the agency?

Source document text, dates, docket IDs, and authority are extracted directly from FDA.

What's AI-generated?

The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.

Last updated

Classification

Agency
FDA
Filed
April 8th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1752-2026

Who this affects

Applies to
Patients Healthcare providers Manufacturers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Insulin pump recall Medical device correction Patient safety notification
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Product Safety

Get alerts for this source

We'll email you when FDA: Device Recalls Class II publishes new changes.

Free. Unsubscribe anytime.

You're subscribed!