| Class 2 Device Recall MiniMed Implantable Pump (MIP) | |
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
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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
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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 |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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