Model note · Insulin Pump
Insulet Omnipod 5 Automated Insulin Delivery System
Omnipod 5 is a tubeless patch pump: a disposable Pod with an integrated reservoir and automatic cannula insertion is worn on the body for up to three days and controlled over Bluetooth by a locked down Controller or a smartphone app. In Automated Mode an algorithm hosted on the Pod adjusts insulin using CGM readings; in Manual Mode it follows programmed basal rates. Because the Pod is thrown away every three days, most hardware issues show up as Pod failures rather than repairs.
The model
Maker, model and type.
- Maker
- Insulet Corporation
- Model
- Omnipod 5 Automated Insulin Delivery System (Omnipod 5 ACE Pump Pod with Controller or App)
- Device type
- Insulin Pump
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Basal range | 0.05 to 30 U/h in 0.05 U steps | Source |
| Bolus range and maximum rate | 0.05 to 30 U in 0.05 U steps; up to 1.5 U per minute | Source |
| Delivery accuracy (IEC 60601-2-24) | Basal plus or minus 5% at 0.05 U/h or more; bolus plus or minus 5% at 1.0 U or more, plus or minus 0.05 U below 1.0 U | Source |
| Occlusion detection | At 5.0 units | Source |
| Pumping mechanism | Microprocessor driven step drive turning a leadscrew against a syringe style reservoir | Source |
| Wear time and power | Up to three days per Pod; disposable batteries in the Pod | Source |
| Operating environment | 5 to 40 degrees C, 20 to 85% relative humidity | Source |
| Event memory and shelf life | Events stored on the Controller for up to 90 days; Pod shelf life 18 months, EtO sterilised | Source |
| Insulin | U-100 insulin | Source |
| FDA clearance | K203768, Omnipod 5 ACE Pump (Pod), 27 January 2022, product code QFG, predicate Omnipod DASH (K191679) | Source |
Recalls
Known FDA recalls.
- Z-2603-20262026-05-20
External soft cannula damage causing insulin to leak around the Pod.
FDA record - Z-1797-20262026-03-12
Internal soft cannula tear in Pods from 49 lots, leaking insulin into the Pod.
FDA record - Z-0132-20262025-09-11
iOS app: holding a field with iPhone magnifier could duplicate digits in manual entries.
FDA record - Z-2016-20252025-05-23
iOS app did not accept a comma decimal separator in some regional settings.
FDA record - Z-0591-20242023-11-30
Android app bolus calculator dropped a leading decimal point.
FDA record - Z-0423-20232022-11-14
Controller charging port and cable could overheat, melt or fail to charge.
FDA record
Safety
Safety warnings from the record.
Sources
Where this note comes from.
- FDA 510(k) K203768 summary, Omnipod 5 ACE Pump (Pod)
- openFDA recall search, Omnipod 5
- openFDA MAUDE problem counts, brand OMNIPOD 5
Not covered: Alarm names come from the 510(k) comparison table; exact on screen wording and troubleshooting steps are in the Omnipod 5 user guide, which was not read, so first checks for each alarm are kept general. Reservoir volume and Pod dimensions were not in the summary. The Pod is disposable, so there are no service parts. MAUDE counts are extremely high due to summary reporting and are not failure rates. The manufacturerUrl points to the FDA summary.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Insulin Pump