Reported Jun 10, 2020 · Terminated
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Medtronic Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219
Is this the product you have?
- Medtronic Implantable Insulin Pump System
- REFMMT-2007D, Sterile EO
- CE 0459 UDI00763000043001
- Lot codes and dates
- Device not distributed within the US. All Pump lots produced May 21, 2019 to present
- containing the following serial numbers
3135931360and 31332
- Amount recalled
- 24 Pumps
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.
This product could cause temporary or reversible health problems — stop using it.
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