Use caution Medical device recall · FDA · Published April 10, 2020

Medtronic Insulin Pump Recall: Endotoxin Risk May Cause Serious Health Issues

Medtronic recalls insulin pumps with specific serial numbers due to potential endotoxin levels that could cause fever, hypotension, or life-threatening reactions. Affected pumps were produced from May 21, 2019 onward.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2206-2020Medical device Medtronic ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmMedtronic Inc.18000 Devonshire St · Northridge, CA 91325-1219

✎ GovInfoNow plain-language explainer

Medtronic is recalling insulin pumps with certain serial numbers because they may contain higher than allowed endotoxin levels. This could lead to serious health issues like fever, low blood pressure, or even death in rare cases. Read more at govinfonow.com/recall/65449-medtronic-insulin-pump-recall-endotoxin-risk-may-cause-serious-health.

Source Summary by GovInfoNow · govinfonow.com/recall/65449-medtronic-insulin-pump-recall-endotoxin-risk-may-cause-serious-health · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2206-2020

Cite this page

“Medtronic Insulin Pump Recall: Endotoxin Risk May Cause Serious Health Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65449-medtronic-insulin-pump-recall-endotoxin-risk-may-cause-serious-health. Based on FDA recall #Z-2206-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2206-2020%22&limit=1).

The FDA announced on April 10, 2020, that Medtronic Inc. is recalling its Implantable Insulin Pump System due to potential endotoxin contamination. This hazard could cause fever, shock, or death in patients. The recall affects pumps distributed outside the U.S.

How to tell if you have it

Brand: Medtronic
Product: Medtronic Implantable Insulin Pump System
REF: MMT-2007D
UDI: 00763000043001
Lots produced May 21, 2019 to present
Serial numbers: 31359, 31360, and 31332
Quantity: 24 pumps

The hazard

Internal testing showed the device did not meet specifications for endotoxin levels. If pumps have higher than allowed endotoxin levels, patients may experience fever, hypotension, anaphylactic shock, hyperglycemia, or diabetic ketoacidosis (DKA). These conditions can potentially lead to secondary multi-organ failure and/or death.

Context

GovInfoNow's records show Medtronic has 38 other recalls on record since September 10, 2017. Recent similar insulin pump recalls include the MiniMed 780G (July 13, 2026) and the MiniMed 670G (July 13, 2026), both citing risks of incorrect insulin delivery. Other recent Medtronic device recalls involve the Sphere-9 Catheter (March 11, 2026) and the Abre Venous Stent (December 4, 2025).

How to tell if you have this one

Check your insulin pump's serial number. Affected pumps have serial numbers 31359, 31360, or 31332 and were produced from May 21, 2019 onward.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Pump Serial Number
Look for the serial number on your insulin pump. Affected pumps have serial numbers 31359, 31360, or 31332.
Contact Medtronic
Reach out to Medtronic directly for further assistance or to confirm if your pump is affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 13 months after the firm started it.

Apr 10, 2020Firm started the recall
Jun 2, 2020FDA classified it Class II
Jun 10, 2020Published in FDA’s Enforcement Report
Apr 27, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are these pumps still available in the US?

No, these pumps were not distributed within the US.

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Link to this recall

<a href="https://govinfonow.com/recall/65449-medtronic-insulin-pump-recall-endotoxin-risk-may-cause-serious-health">Medtronic Insulin Pump Recall: Endotoxin Risk May Cause Serious Health Issues (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2206-2020 (April 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2206-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.