Paradigm REF: MMT-712 and MMT-715

FDA device recall Z-1255-2025 · posted 2025-03-03 · Open, Classified

Recall details

Recalling firm

Medtronic MiniMed, Inc.

Reason for recall

All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. During a delivery accuracy dry run testing of the 780G NGP infusion pump under dynamic pressure conditions, the firm observed that when air pressure decreased during take-off simulation, on average 0.569U more insulin was delivered in 15 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate; when air pressure increased during landing simulation, on average 0.537 U less insulin was delivered in 25 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate. The firm also observed that the mechanisms causing the variations in delivery volumes are independent of the delivery rate.

Action taken

On January 31, 2025, Medtronic MiniMed issued a "Urgent Medical Device Correction" notification to all affected consignees. The notification was distributed via: e-mail, certified mail, SMS text message or phone call. 1. Monitor Your Glucose Levels: 2. Discuss how to prepare for situations like this with your healthcare professional. 3. Respond to Alerts and Symptoms. 4. Please acknowledge that you have read and understood this notification and have followed the actions listed in this letter by either completing and returning the confirmation form, scanning the QR code below with your phone or tablet, or by visiting [https://info.medtronicdiabetes.com/pump-delivery-volume] to acknowledge this communication.

Root cause

Device Design

Status

Open, Classified

Product code

LZG

Quantity affected

20,760 units

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV

Date initiated

2025-01-31

Date posted

2025-03-03

Location

Northridge, CA

Related 510(k) clearances