| Class 2 Device Recall MiniMed 640G Insulin Infusion Pump | |
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
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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
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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. |
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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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