FDA Device recall Z-1354-2022
MiniMed 640G Insulin Pump (O.U.S. Version)
- FDA Device
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of MiniMed 640G Insulin Pump (O.U.S. Version) by Medtronic Minimed, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1354-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-23 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Minimed |
| Distribution | 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, VT, WA, WI, WV, WY |
Product
MiniMed 640G Insulin Pump (O.U.S. Version)
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 loss of power/functionality of the insulin infusion pumps.
Identifiers
| code_info | Product Number/CFN (O.U.S. Version) MiniMed 640G (MMT-1511, MMT-1512, MMT-1711, MMT-1712, MMT-1725 (Pre Prod only), MMT…Product Number/CFN (O.U.S. Version) MiniMed 640G (MMT-1511, MMT-1512, MMT-1711, MMT-1712, MMT-1725 (Pre Prod only), MMT-1751, MMT-1752) UDI Codes: Pending Serial Numbers: NG1000091H NG1000104H NG1000140H NG1000173H NG1000184H NG1000213H NG1000236H NG1000317H NG1000323H NG1000353H NG1000386H NG1000408H NG1000418H NG1000426H NG1000447H NG1000489H NG1000509H NG1000514H NG1000525H NG1000526H NG1000527H NG1000539H NG1000549H NG1000554H NG1000602H NG1000612H NG1000645H NG1000654H NG1000803H NG1000804H NG1000810H NG1000821H NG1000836H NG1000939H NG1000949H NG1000976H NG1001057H NG1001165H NG1001179H NG1001224H NG1001251H NG1001283H NG1001310H NG1001406H NG1001530H NG1001554H NG1001604H NG1001635H NG1001736H NG1001779H NG1001818H NG1001832H NG1001844H NG1001918H NG1001942H NG1001952H NG1001971H NG1001973H NG1002098H NG1002102H NG1002114H NG1002141H NG1002166H NG1002167H NG1002172H NG1002177H NG1002234H NG1002240H NG1002269H NG1002306H NG1002353H NG1002354H NG1002365H NG1002423H NG1002450H NG10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1354-2022%22
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