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U.S. Department of Health and Human Services

Class 2 Device Recall MiniMed 720G Insulin Pump

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  Class 2 Device Recall MiniMed 720G Insulin Pump see related information
Date Initiated by Firm May 23, 2022
Create Date July 08, 2022
Recall Status1 Open3, Classified
Recall Number Z-1356-2022
Recall Event ID 90370
Product Classification Pump, infusion, insulin, to be used with invasive glucose sensor - Product Code OYC
Product MiniMed 720G Insulin Pump (O.U.S. Version)
Code Information Product Number/CFN (O.U.S. Version) MiniMed 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1817, MMT-1867) UDI Codes: Pending Serial Numbers (O.U.S.) NG2820120H NG2820133H NG2820138H NG2820180H NG2820183H NG2820193H NG2820227H NG2820238H NG2820239H NG2820241H NG2820242H NG2820253H NG2820256H NG2820258H NG2820282H NG2820295H NG2820339H NG2820341H NG2820357H NG2820366H NG2820368H NG2820371H NG2820372H NG2820374H NG2820377H NG2820379H NG2820381H NG2820386H NG2820387H NG2820388H NG2820393H NG2820394H NG2820396H NG2820398H NG2820400H NG2820401H NG2820409H NG2820418H NG2820421H NG2820425H NG2820428H NG2820432H NG2820435H NG2820437H NG2820457H NG2820460H NG2820462H NG2820463H NG2820467H NG2820472H NG2820484H NG2820487H NG2820489H NG2820494H NG2820496H NG2820498H NG2820501H NG2820503H NG2820510H NG2820512H NG2820513H NG2820518H NG2820522H NG2820523H NG2820525H NG2820529H NG2820533H NG2820535H NG2820539H NG2820542H NG2820549H NG2820557H NG2820559H NG2820561H NG2820567H 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Recalling Firm/
Manufacturer		 Medtronic MiniMed
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Medtronic Diabetes Technical Support
800-646-4633 Ext. 1
Manufacturer Reason
for Recall		 Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.
FDA Determined
Cause 2		 Device Design
Action On 05/24/2022, Medtronic began communicating an "URGENT MEDICAL DEVICE CORRECTION" Letter to customers informing them of the battery cap issue where if the metal contact becomes loose or falls off from the battery cap, it can result in an incomplete battery connection, leading to no power source to the insulin pump. Actions Required by customers: Before beginning: Do not remove the battery cap unless you have a new battery available. If you have a spare undamaged battery cap, ensure it is available nearby. During routine battery replacement, check the metal contact on your pump battery cap to see if it is loose, damaged, or missing. You can view animated instructions on how to inspect the battery cap contact through our website at www.medtronicdiabetes.com/battery-cap-guide. " If the battery cap contact is damaged, immediately replace it with a spare cap that you received with original pump shipment, and discard the damaged cap. If no spare cap, stop using pump and revert to a back-up plan per healthcare provider s recommendations. Then, request a spare battery cap online at www.medtronicdiabetes.com/battery-cap-form, or contact Medtronic 24-Hour Technical Support at 877-496-7933. " If unsure that the battery cap contact are damaged, replace it with a spare cap or request a spare battery cap online at www.medtronicdiabetes.com/battery-cap-form, or contact Medtronic 24-Hour Technical Support at 877-496-7933. " If the battery cap contact is not damaged, continue to use your pump and monitor for cap damage during battery replacement, and complete and return the attached confirmation form by mail. Medtronic will send you a spare cap in the coming months. " Always pay close attention to the pump and pump battery status after inserting the new battery. For questions, contact Medtronic 24-Hour Technical Support at 877-496-7933.
Quantity in Commerce 575 pumps
Distribution U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY O.U.S.: Not provided
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 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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