medical Class II Updated 2020-06-10

Medtronic Inc. recalls Medtronic Implantable Insulin Pump System, REF: MMT-2007D, S

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: No US Distribution. OUS: Netherlands, France, and Sweden
Lot/Code Info: Device not distributed within the US. All Pump lots produced May 21, 2019 to present containing the following serial numbers: 31359, 31360, and 31332
View official government recall

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