Recall Z-2206-2020— Medtronic Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., initiated 2020-04-10, terminated 2021-04-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001. Reason: 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..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-10
- Terminated
- 2021-04-27
- Firm location
- Northridge, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.