Medtronic Recalls Paradigm Insulin Pumps Due to Cap Detachment Risk
Medtronic is recalling Paradigm insulin infusion pumps because a drive support cap may detach and allow water to damage internal electronics.
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 involves a high-risk medical device (insulin pump) where a mechanical defect could lead to device malfunction (buttons not working or alarms), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Medtronic MiniMed is recalling approximately 428,000 Paradigm insulin infusion pumps, including models MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. These devices are intended to deliver basal and bolus insulin to persons with diabetes.
The recall is being issued because the pump's drive support cap may become detached from the pump case and protrude from the lower right side. If the pump is exposed to water, this defect may result in damage to the pump's internal electronics. This moisture damage can prevent the pump's buttons from working properly or can cause the pump to alarm.
The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries. Users of these devices should contact Medtronic MiniMed for instructions on how to proceed with the recall.
The recalled product
- Product
- Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. Product Usage: Paradigm insulin infusion pumps are…
- Manufacturer
- Medtronic MiniMed
- Affected units
- 428,000
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)
- Not available
Distribution
Distributed nationwide across the United States.
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