FDAFDA · Food and drugs·Recall number Z-2206-2020
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Published June 10, 2020 · Recall initiated: April 10, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Medtronic Inc.
- Distributor
- No US Distribution. OUS: Netherlands, France, and Sweden
- Lot
- Device not distributed within the US. All Pump lots produced May 21, 2019 to present containing the following serial numbers: 31359, 31360, and 31332
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.