Class 1 Device Recall Mini Med 630G System with SmartGuard

• Date Initiated by Firm: November 21, 2019
• Date Posted: February 07, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0955-2020
• Recall Event ID: 84430
• PMA Number: P150001
• Product Classification: Automated insulin dosing , threshold suspend - Product Code OZO
• Product: Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
• Code Information: All Serial Numbers ( excluding devices with black retainer rings)
• Recalling Firm/ Manufacturer: Medtronic Inc.; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: Khristina Anastasopoulos; 818-576-3398
• Manufacturer Reason for Recall: There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.
• FDA Determined Cause: Device Design
• Action: On November 21, 2019, Medtronic initiated a recall of MiniMed 600 series insulin pumps with a clear retainer ring design. On October 5, 2021, the firm expanded the recall and issued an "Urgent Field Safety Notification" to all patients and health care providers. The updated notification informs consignees that Medtronic will proactively replace all MiniMed 600 series insulin pumps that have a clear retainer ring design with an equivalent pump that has the updated black retainer ring design. Pumps will be replaced at no charge over the coming months even if the retainer ring is not damaged and regardless of the warranty status of the pump. In addition to providing consignees with this updated recall strategy, the firm asked consignees to take the following actions: ACTIONS REQUIRED BY YOU: 1. Complete and return the attached Confirmation Form to acknowledge that you have reviewed and understood this notification. 2. Medtronic is requesting patients visit [www.medtronicdiabetes.com/PumpRing] and complete the form online, or call us at 1-877-585-0166 to indicate their decision to receive a replacement pump at no charge. Replacement pumps will become available in the coming months and patients will be notified when their pump is ready to ship. Please assist patients in making replacement decision considering the safety risk associated with the retainer ring issue. For additional recall details, please view the following link: https://www.medtronicdiabetes.com/customer-support/product-and-service-updates/notice15-letter
• Distribution: US:AK,AL,AR,AZ,BM,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, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: France, Germany, UK, Italy, Netherlands, Spain, Sweden, Israel, Norway, Austria, Belgium, Denmark, Czech Republic, Finland, Switzerland, Slovakia, Ireland, Poland, S. Africa, Greece, Hungary, Saudi Arabia, United Arab Emira, New Zealand, Australia, Japan, Mexico, Colombia, Brazil, S. East Asia, Korea, Canada,
• 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.

• PMA Database: PMAs with Product Code = OZO and Original Applicant = MEDTRONIC MINIMED