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

Recall date

April 10, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2206-2020

FDA classification

Class II

Brand / firm

Medtronic Inc.

Sold / distributed

No US Distribution. OUS: Netherlands, France, and Sweden

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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