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Class 2 Device Recall MiniMed 740G Insulin Pump |
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| Date Initiated by Firm |
May 23, 2022 |
| Create Date |
July 08, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1357-2022 |
| Recall Event ID |
90370 |
| Product Classification |
Pump, infusion, insulin, to be used with invasive glucose sensor - Product Code OYC
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| Product |
MiniMed 740G Insulin Pump (O.U.S. Version)
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| Code Information |
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
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Recalling Firm/
Manufacturer |
Medtronic MiniMed
18000 Devonshire St
Northridge CA 91325-1219
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| For Additional Information Contact |
Medtronic Diabetes Technical Support
800-646-4633 Ext. 1
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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.
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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.
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| 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 |
| 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 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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