Class 2 Device Recall Medtronic MiniMed Paradigm Reservoirs

• Date Initiated by Firm: July 03, 2013
• Date Posted: August 20, 2013
• Recall Status: Terminated on January 16, 2014
• Recall Number: Z-1986-2013
• Recall Event ID: 65644
• 510(K)Number: K001828 K032005
• Product Classification: Pump, infusion - Product Code FRN
• Product: Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL); ; The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically, the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. ; Product Quantity Distributed (Int) 669,672 units
• Code Information: MMT-326A Lot Numbers: H8437486 H8441420 H8442973 H8451531 H8486688 H8489386 H8485398 H8500423 H8500472 H8503728 H8512826 H8503372 H8510440 H8539013 H8627745 MMT-332A Lot Numbers: H8416432 H8420977 H8422490 H8424676 H8452933 H8455959 H8457716 H8459557 H8461538 H8463297 H8464121 H8467888 H8469703 H8471745 H8473271 H8476270 H8478398 H8473106 H8492449 H8491921 H8494645 H8496561 H8509305 H8512566 H8515317 H8517079 H8521052 H8541843 H8584244 H8603292 H8604958 H8635301
• Recalling Firm/ Manufacturer: Medtronic MiniMed; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: 818-567-4700
• Manufacturer 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
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 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, Singapore, Uruguay and Venezuela.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = MEDTRONIC MINIMED; 510(K)s with Product Code = FRN and Original Applicant = MINIMED, INC.