FDA Device recall Z-1751-2026
MiniMed 530G Insulin Pump (MMT-551, MMT-751)
- FDA Device
- Class II
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class II recall of MiniMed 530G Insulin Pump (MMT-551, MMT-751) by Medtronic Minimed, citing all Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1751-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-13 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medtronic Minimed |
| Distribution | US |
Product
MiniMed 530G Insulin Pump (MMT-551, MMT-751)
Reason
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Identifiers
| code_info | Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 530G: 00643169507784, 00643169736061, 00643169736092, 00643…Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 530G: 00643169507784, 00643169736061, 00643169736092, 00643169736085, 00643169933224, 00763000161170: Artwork, CRB A Process, Instr, 530G, One Press, Launch, US(MP6026081-012DOC); Artwork, CRB A Process, Instr, 530G, FDA comments, add TST(MP6025813-013DOC); Artwork, CRB A Process, Instr, 530G, Remove Velcro, Icons, US(MP6025813-014DOC); |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1751-2026%22
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