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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic MiniMed Implantable Insulin Pump

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  Class 2 Device Recall Medtronic MiniMed Implantable Insulin Pump see related information
Date Initiated by Firm June 16, 2014
Date Posted August 08, 2014
Recall Status1 Terminated 3 on September 25, 2014
Recall Number Z-2173-2014
Recall Event ID 68633
Product Classification Pump, infusion - Product Code FRN
Product Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
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 Implantable Insulin Pump because there have been reports of a pump malfunction resulting in the disconnection of the delivery of insulin prior to the end of the 7 year useful life of the device.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent Field Safety Notice Letter dated 6/16/14 was sent to all customers who purchased the Medtronic Implantable Insulin Pump. The letter informs the customers of the problems identified and the actions to be taken. Customers are informed that Medtronic MiniMed is working to make new unaffected pumps available as soon as possible. Customers are instructed to contact Elisabeth Andrieu at + 33 6 89 71 9056 or Dr. Francine Kaufman at +1 818.576.5331.
Quantity in Commerce 764 units
Distribution New Jersey and Worldwide: Belgium, France, Netherland, and Sweden
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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