FDA Device recall Z-0438-2016
MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump systems are indicat…
- FDA Device
- Class II
- terminated
- Published 2015-12-23
On 2015-12-23 the FDA classified a Class II recall of MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump systems are indicat… by Medtronic Minimed, citing the pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. Possible cause is eith….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0438-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-25 |
| Published | 2015-12-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Minimed |
| Distribution | n/a |
Product
MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump system is indicated for continuous monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes.
Reason
The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. Possible cause is either lack of greasing or deficient greasing in a ball bearing assembly of the motor.
Identifiers
| code_info | NG1000742H NG1001185H NG1001199H NG1001204H NG1001206H NG1002461H NG1006813H NG1007995H NG1013701H NG1015570H…NG1000742H NG1001185H NG1001199H NG1001204H NG1001206H NG1002461H NG1006813H NG1007995H NG1013701H NG1015570H NG1016916H NG1017305H NG1019509H NG1019517H NG1019519H NG1019521H NG1019522H NG1019523H NG1019528H NG1019530H NG1019533H NG1019534H NG1019536H NG1019543H NG1019544H NG1019547H NG1019549H NG1019550H NG1019551H NG1019553H NG1019555H NG1019556H NG1019557H NG1019558H NG1019559H NG1019561H NG1019562H NG1019564H NG1019565H NG1019566H NG1019567H NG1019568H NG1019569H NG1019571H NG1019572H NG1019573H NG1019576H NG1019577H NG1019578H NG1019579H NG1019580H NG1019581H NG1019583H NG1019585H NG1019586H NG1019587H NG1019588H NG1019589H NG1019590H NG1019591H NG1019595H NG1019596H NG1019597H NG1019598H NG1019600H NG1019601H NG1019602H NG1019603H NG1019604H NG1019606H NG1019607H NG1019608H NG1019609H NG1019610H NG1019611H NG1019612H NG1019613H NG1019615H NG1019616H NG1019617H NG1019618H NG1019619H NG1019620H NG10 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0438-2016%22
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