Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A a

FDA device recall Z-1986-2013 · posted 2013-08-20 · Terminated

Recall details

Recalling firm

Medtronic MiniMed

Reason for recall

Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if there is a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not

Action taken

An Urgent Medical Device Recall notice was sent to customers on July 3, 2013, who purchased the Medtronic Paradigm Reservoirs MMT-326A and MMT-332A. The recall letter informed the customers of the problems and the actions to be taken. Medtronic instructed customers that they will replace all reservoirs from the affected lots at no cost. Customers are instructed to refer to www.medtronicdiabetes.com/support/product-updates for a list of frequently asked questions. Customers are instructed to report adverse reactions or quality problems experienced with the use of Medtronic Diabetes insulin pumps, infusion sets or reservoirs to FDA's MedWatch Adverse Event Reporting Program. Customers are instructed to call for replacements at (866) 222-2584 Monday through Friday (8am-6pm) central time. Customers with an urgent issue may use the 24 hour helpline.

Root cause

Under Investigation by firm

Status

Terminated

Product code

FRN

Quantity affected

669,672 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Japan, Mexico, Netherland, Paraguay, Puerto Rico, Sin

Date initiated

2013-07-03

Date posted

2013-08-20

Date terminated

2014-01-16

Location

Northridge, CA

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