FDAApril 10, 2020device

Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

medtronic

UPCs

00763000043001

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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