Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets Recalled by Medtronic MiniMed Due to Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic...

Date: June 7, 2013
Company: Medtronic MiniMed
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic MiniMed directly.

Affected Products

Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.

Quantity: 11,000,000 units

Why Was This Recalled?

Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic MiniMed

Medtronic MiniMed has 31 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report