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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic MiniMed

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  Class 2 Device Recall Medtronic MiniMed see related information
Date Initiated by Firm June 19, 2015
Date Posted July 24, 2015
Recall Status1 Terminated 3 on October 02, 2015
Recall Number Z-2260-2015
Recall Event ID 70897
Product Classification Pump, infusion - Product Code FRN
Product MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.
Code Information n/a
Recalling Firm/
Manufacturer		 Medtronic MiniMed Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact
818-567-4700
Manufacturer Reason
for Recall		 Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.
FDA Determined
Cause 2		 Under Investigation by firm
Action A customern notification letter sent to customers on 6/19/15 who received the MiniMed 640G insulin pumps. The purpose of the letter is to inform customers that when using Bolus Wizard with the MiniMed 640G insulin pumps, that there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate. Customers are informed that Medtronic MiniMed has updated the user guide which instructs to respond promptly to set Bolus screens, and remind not to activate delivery on a bolus based on a blood glucose value that is more than 12 minutes old. The letter informs the customers of the summary of changes in the MiniMed 640G insulin pump user guides.
Quantity in Commerce 1936 units
Distribution Australia, Czech Republic, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden, United Kingdom.
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.
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