Class 2 Device Recall Medtronic MiniMed(TM) Proset(TM)

• Date Initiated by Firm: September 10, 2017
• Create Date: November 18, 2017
• Recall Status: Open, Classified
• Recall Number: Z-0111-2018
• Recall Event ID: 78125
• 510(K)Number: K160651
• Product Classification: Tubing, fluid delivery - Product Code FPK
• Product: Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
• Code Information: Lot Numbers: 6211649, 6207537
• Recalling Firm/ Manufacturer: Medtronic Inc.; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: Medtronic; 888-204-7616
• Manufacturer Reason for Recall: Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
• FDA Determined Cause: Component design/selection
• Action: The firm initiated its recall on 09/11/2017 by issuing a public notice, following with letters and emails. The firm also employed the use of Facebook and Twitter as well as posting on its website. The recall notice directs the customer to visit https://checklots.medtronicdiabetes.com for information on the lot numbers. Persons with additional questions may call Medtronic at 1.888.204.7616.
• Quantity in Commerce: 5,842 units
• Distribution: Worldwide
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FPK