Medtronic Implantable Insulin Pump System — Class II medical device recall Z-2206-2020
Terminated recall by Medtronic Inc., reported 2020-06-10. Internal testing results showed endotoxin-related test result did not meet specifications for implantable insu
| Recall number | Z-2206-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Northridge, CA, United States |
| Recall initiated | 2020-04-10 |
| Classified | 2020-06-02 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2021-04-27 |
| Countries outside the US | FR, NL, SE |
| Quantity | 24 pumps |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00763000043001 |
| Serial numbers | 31332, 31359, 31360 |
| Model numbers | MMT-2007D |
Product
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Reason for recall
Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than allowed endotoxin levels, patients may have an effect of fever, hypotension, anaphylactic shock, hyperglycemia, or diabetic ketoacidosis (DKA), potentially followed by secondary multi-organ failure (primarily renal and hepatic) and/or death.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2206-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.