RecallDepth

MiniMed 740G Insulin Pump (O.U.S. Version)

Company
Medtronic Minimed
Recall Initiated
May 23, 2022
Recall Number
Z-1357-2022
Quantity
40 pumps
Firm Location
Northridge, CA

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.

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

Lot / Code Info

Product Number/CFN (O.U.S. Version) MiniMed" 740G pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) UDI Codes: Pending Serial Numbers (O.U.S.): NG2644996H NG2645006H NG2645007H NG2645013H NG2645014H NG2645023H NG2645025H NG2645026H NG2645030H NG2645032H NG2645051H NG2645062H NG2645065H NG2645066H NG2645067H NG2645074H NG2645077H NG2645081H NG2645086H NG2645097H NG2645100H NG2645101H NG2645115H NG2645116H NG2645117H NG2645119H NG2645120H NG2645122H NG2645125H NG2645127H NG2645128H NG2645139H NG2645143H NG2645146H NG2645148H NG2645150H NG2645151H NG2645164H NG2645178H NG2645213H

Root Cause

Device Design

Action Taken

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.

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