Medtronic MiniMed Implantable Insulin Pump Recalled for Malfunction
Medtronic MiniMed is recalling 764 Implantable Insulin Pumps due to reports of pump malfunction causing insulin delivery to stop before the device's 7-year useful life ends.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the cessation of insulin delivery, which is a significant risk of harm for patients with diabetes, but the source text does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic MiniMed Inc. is recalling 764 units of the Implantable Insulin Pump, Model No. MMT-2007D. The recall is being conducted because there have been reports of a pump malfunction that resulted in the disconnection of insulin delivery prior to the end of the device's 7-year useful life.
The affected devices were distributed in New Jersey and worldwide, specifically in Belgium, France, the Netherlands, and Sweden. The source text does not specify the exact number of units distributed in each location or the specific dates of distribution.
Consumers and healthcare providers with this specific model of implantable insulin pump should contact Medtronic MiniMed for further instructions on how to proceed. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
- Manufacturer
- Medtronic MiniMed Inc.
- Affected units
- 764
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 (1)
- n/a
Distribution
Distributed in 1 state:
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