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Recall Observatory FDA recall evidence

Device product

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

Z-2206-2020

April 10, 2020

Class II

Product summary

Firm
Medtronic Inc.
Event
Event 85582
Status
Terminated
Classification
Class II
Quantity
24 Pumps
Official record key
device-enforcement:Z-2206-2020

Official wording

Reason: 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.

Code information: Device not distributed within the US. All Pump lots produced May 21, 2019 to present containing the following serial numbers: 31359, 31360, and 31332

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.