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.
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.
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.
The pumps may have higher endotoxin levels than safe limits. Endotoxins can cause fever, low blood pressure, severe allergic reactions, or life-threatening conditions like diabetic ketoacidosis, which can lead to organ failure.
People with insulin pumps using the specific serial numbers listed in the recall are affected. Diabetic patients using these pumps are at the highest risk.
Check your insulin pump's serial number. Affected pumps have serial numbers 31359, 31360, or 31332 and were produced from May 21, 2019 onward.
Look for the serial number on your insulin pump. Affected pumps have serial numbers 31359, 31360, or 31332.
Reach out to Medtronic directly for further assistance or to confirm if your pump is affected.
No, these pumps were not distributed within the US.
Higher endotoxin levels may cause fever, low blood pressure, anaphylactic shock, hyperglycemia, or diabetic ketoacidosis, which can lead to organ failure or death.
Check your pump's serial number. Affected pumps have serial numbers 31359, 31360, or 31332 and were produced from May 21, 2019 onward.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2206-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2206-2020 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
