Medtronic Implantable Insulin Pump Recalled for Endotoxin Contamination
Medtronic is recalling 24 implantable insulin pumps due to endotoxin levels exceeding specifications. The devices were distributed only in the Netherlands, France, and Sweden.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the hazard can potentially lead to death, which aligns with the rubric criteria for a Severe (4) rating involving significant injury or death reports.
Plain-English summary
Medtronic Inc. is recalling 24 units of the Implantable Insulin Pump System (REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001). The recall was initiated after internal testing revealed that endotoxin-related test results did not meet specifications for the implantable insulin pump.
The affected devices are all pump lots produced from May 21, 2019, to the present, containing serial numbers 31359, 31360, and 31332. These devices were not distributed within the United States. Distribution was limited to the Netherlands, France, and Sweden.
If the pumps contain higher than allowed endotoxin levels, patients may experience fever, hypotension, anaphylactic shock, hyperglycemia, or diabetic ketoacidosis (DKA). These conditions can potentially lead to secondary multi-organ failure, primarily renal and hepatic, and/or death.
The recalled product
- Product
- Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
- Manufacturer
- Medtronic Inc.
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Device not distributed within the US. All Pump lots produced May 21
- 2019 to present containing the following serial numbers: 31359
- 31360
- and 31332
Distribution
Distribution scope not specified by the agency.
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