FDA recall Z-2206-2020

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-04-10

Report date

2020-06-10

Termination date

2021-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northridge, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2206-2020