Medical Device
Manufacturing
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Z-1357-2022Class II

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

Medtronic, Inc. / initiated 2022-05-23 / Open, Classified / root cause: design

Medtronic MiniMed began a recall of MiniMed 740G Insulin Pump (O.U.S. Version) on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-1357-2022
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Medtronic, Inc.
Product
MiniMed 740G Insulin Pump (O.U.S. Version)
Product code
OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
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.
Root cause tag
design
FDA root cause
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
40 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
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1357-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1352-2022Class IIOngoingVoluntary: Firm initiated
Z-1353-2022Class IIOngoingVoluntary: Firm initiated
Z-1354-2022Class IIOngoingVoluntary: Firm initiated
Z-1355-2022Class IIOngoingVoluntary: Firm initiated
Z-1356-2022Class IIOngoingVoluntary: Firm initiated
Z-1357-2022Class IIOngoingVoluntary: Firm initiated
Z-1358-2022Class IIOngoingVoluntary: Firm initiated
Z-1359-2022Class IIOngoingVoluntary: Firm initiated