Class II recall Z-0203-2027: Medtronic MiniMed, Inc.
Class II recall Z-0203-2027: Medtronic MiniMed, Inc. (California): Medtronic MiniMed, Inc. Dated 8 days ago, it is in the active follow-up window. Score 68/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0203-2027 |
| Recalling firm | Medtronic MiniMed, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | CareLink Clinic, REF: MMT-7350 |
| Reason | CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or Long-acting insulin when calculating the Carb Ratio, Insulin Sensitivity Factor (ISF), and Max Recommended value for Rapid-acting insulin. Instead, the calculator continues to use the system-recommended values, resulting in incorrect rapid-acting insulin parameters. If an HCP or patient inputs these incorrect setting values into the patient's MiniMed Go app, the patient could deliver higher or lower insulin doses compared to their insulin needs, potentially leading to over/under delivery of insulin with a severity ranging from Catastrophic (death from severe hypo |
| Quantity | 1 |
| Distribution | US Nationwide distribution in the state of KS. |
| Recall initiated | 2026-09-11 |
| Reported | 2026-10-28 |
| Firm location | Northridge, CA, United States |
| Peer records CSV (76 CA records) | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-28
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Class II recall Z-0203-2027: Medtronic MiniMed, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
68 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 8 days ago.
What is the FDAPulse record for Class II recall Z-0203-2027: Medtronic MiniMed, Inc. in California?
Class II device recall Z-0203-2027 by Medtronic MiniMed, Inc.: CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calcula
How does Class II recall Z-0203-2027: Medtronic MiniMed, Inc. compare to other California FDAPulse records?
It is fresh: dated 8 days ago, inside the window where early outreach matters most.
Class II recall Z-0203-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0203-2027 | CA | 2026-10-28 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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