Medtronic Implantable Insulin Pump System recall: Endotoxin
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Why was Medtronic Implantable Insulin Pump System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Device not distributed within the US. All Pump lots produced May 21, 2019 to present containing the following serial numbers: 31359, 31360, and 31332
- Product
- Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
- Recalling firm
- Medtronic Inc.
- Quantity
- 24 Pumps
- Distribution
- No US Distribution. OUS: Netherlands, France, and Sweden
- Recall date
- June 10, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)