FDA-Device2020-06-10Class II
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Medtronic Inc.
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.
Sold states
No US Distribution. OUS: Netherlands, France, and Sweden
Affected count
24 Pumps
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Products
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2206-2020Don't want to check this manually?
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