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U.S. Department of Health and Human Services

Class 2 Device Recall MiniMed 640G Insulin Infusion Pump

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  Class 2 Device Recall MiniMed 640G Insulin Infusion Pump see related information
Date Initiated by Firm April 30, 2020
Create Date December 02, 2020
Recall Status1 Open3, Classified
Recall Number Z-0518-2021
Recall Event ID 85711
Product Classification unknown device name - Product Code N/A
Product MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Code Information All serial numbers expiration date- 3 years from date of manufacture: NG2095284H, NG2095319H   
Recalling Firm/
Manufacturer		 Medtronic Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Pamela Reese
818-576-4700
Manufacturer Reason
for Recall		 Missing solder battery connection, which could interrupt power of insulin pump.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On April 30, 2020, the firm mailed a "Urgent Medical Device Recall" letter to patients. The firm also sent a letter to Health Care Professionals, (HCP) "Urgent Medical Device Recall" that they read this notice and confirm receipt that the customer read and understood the instructions provided in this letter. The letter notified customers that the insulin pumps had an issue on the battery connection that did not meet firm's quality specifications. If power is interrupted on a patients insulin pump, then insulin is suspended, which may lead to hyperglycemia (high blood sugar). There have been no reported complaints from customers as a result of this issue. The firm identified the pump models, serial numbers of the affected devices. In addition to informing patients about the recall, the letter asked patients to do the following: (1) Record current pump settings. Follow the System User Guide to set up new pump that is enclosed in the box. (2) After successfully programming the replacement pump, start using replacement pump. (3) Return affected pump using the included shipping materials. Contact 24-Hour Technical Support at 1-877-585-0166, the instructions provided in this letter. The firm sent a letter to Health Care Professionals, (HCP) "Urgent Medical Device Recall" that they read this notice and confirm receipt that the customer read and understood lead to hyperglycemia (high blood sugar). There have been no reported complaints from customers as a result of this issue. The firm identified the pump models, serial numbers of the affected devices.
Quantity in Commerce 2
Distribution Worldwide distribution - U.S. Nationwide Distribution in the state of MD and the countries of Canada, Netherlands, Norway. ***Model 630G distributed in Canada and Model 670G distributed in US ***MODEL640G Distributed OUS ONLY*** OUS: Australia, Canada, Netherlands and Norway.
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.
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