Home › Device types › QFG
Alternate Controller Enabled Insulin Infusion Pump
FDA product code QFG · Class 2 · Clinical Chemistry
124
Registered devices
1,335,840
Adverse events
23
Recalls
29
510(k) clearances
Devices with this code
iLet Bionic Pancreas — Beta Bionics, Inc.Tandem Mobi Autosoft XC Kit — Tandem Diabetes Care, Inc.t:slim X2 Insulin Pump with Basal-IQ — Tandem Diabetes Care, Inc.t:slim X2 Insulin Pump with Basal-IQ — Tandem Diabetes Care, Inc.t:slim X2 Insulin Pump with Control-IQ Technology — Tandem Diabetes Care, Inc.iLet Connect Adapter 15-Pack (BB3052) — Beta Bionics, Inc.t:slim X2 Insulin Pump with Control-IQ — Tandem Diabetes Care, Inc.Tandem Mobi Mobile Application — Tandem Diabetes Care, Inc.iLet Insulin Infusion Kit — Beta Bionics, Inc.Tandem Mobi Autosoft 30 Kit — Tandem Diabetes Care, Inc.t:slim X2 Insulin Pump with Control-IQ — Tandem Diabetes Care, Inc.Tandem Mobi — Tandem Diabetes Care, Inc.iLet Bionic Pancreas — Beta Bionics, Inc.Omnipod 5 Controller APP — Insulet CorporationTandem t:slim Autosoft 30 kit — Tandem Diabetes Care, Inc.Tandem t:slim Autosoft XC Kit — Tandem Diabetes Care, Inc.t:slim X2 Insulin Pump with Control-IQ — Tandem Diabetes Care, Inc.Tandem Mobi — Tandem Diabetes Care, Inc.iLet Bionic Pancreas — Beta Bionics, Inc.iLet Cartridge Kit 15-Pack (1.6mL/160 Units) — Beta Bionics, Inc.Tandem Mobi — Tandem Diabetes Care, Inc.t:slim X2 Insulin Pump with Control-IQ+ Technology — Tandem Diabetes Care, Inc.Tandem Mobi Autosoft XC Kit — Tandem Diabetes Care, Inc.Tandem Mobi Autosoft XC Kit — Tandem Diabetes Care, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-20 | Medtronic MiniMed, Inc. | Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verifi |
| 2026-07-16 | Tandem Diabetes Care, Inc. | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application wi |
| 2026-07-13 | Medtronic MiniMed, Inc. | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result i |
| 2026-07-13 | Medtronic MiniMed, Inc. | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result i |
| 2026-05-27 | Medtronic MiniMed, Inc. | A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and d |
| 2026-05-20 | Insulet Corporation | External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or b |
| 2026-03-12 | Insulet Corporation | Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of be |
| 2026-03-12 | Beta Bionics, Inc. | insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to |
| 2026-02-13 | Medtronic MiniMed, Inc. | 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 insul |
| 2026-01-30 | Tandem Diabetes Care, Inc. | The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infu |
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