Summary
The FDA issued a Class II for MiniMed 740G Insulin Pump (O.U.S. Version) by Medtronic MiniMed. Reason: Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a los.
Details
Source
Device Recall
External ID
Z-1357-2022
Action Date
2022-07-20
Status
Ongoing
Category
device
Product Description
MiniMed 740G Insulin Pump (O.U.S. Version)
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
Quantity Affected: 40 pumps
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-23
Company
Northridge, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic MiniMed has 16 FDA actions in our database, including 12 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic MiniMed) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic MiniMed have FDA actions?
Medtronic MiniMed has 16 FDA actions in our database, including 12 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1357-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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