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U.S. Department of Health and Human Services

Class 2 Device Recall MiniMed Implantable Pump (MIP)

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  Class 2 Device Recall MiniMed Implantable Pump (MIP) see related information
Date Initiated by Firm April 10, 2020
Date Posted June 03, 2020
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-2206-2020
Recall Event ID 85582
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
Product Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Code Information Device not distributed within the US. All Pump lots produced May 21, 2019 to present containing the following serial numbers: 31359, 31360, and 31332 
Recalling Firm/
Manufacturer		 Medtronic Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Pamela Reese
818-576-3398
Manufacturer Reason
for Recall		 Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than allowed endotoxin levels, patients may have an effect of fever, hypotension, anaphylactic shock, hyperglycemia, or diabetic ketoacidosis (DKA), potentially followed by secondary multi-organ failure (primarily renal and hepatic) and/or death.
FDA Determined
Cause 2		 Process control
Action Medtronic initiated verbal communication with affected consignees on April 10, 2020 via phone call and provided affected consignees with an "Urgent Field Safety Notice" via email between the dates of 04/24/20 - 4/30/20. . In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Immediately identify and quarantine all unused affected pumps in your inventory. 2. Return all unused affected pumps in your inventory to Medtronic. Your Medtronic Representative can assist you in the return and replacement of this pump as necessary. 3. Forward this notice to all those who need to be aware within your organization and to any organization where the affected pumps may have been transferred. Please maintain a copy of this notice in your records.
Quantity in Commerce 24 Pumps
Distribution No US Distribution. OUS: Netherlands, France, 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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