Recall Z-2544-2014— Medtronic MiniMed Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic MiniMed Inc., initiated 2014-03-13, terminated 2015-04-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm 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. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.. Reason: Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount..
- Recalling firm
- Medtronic MiniMed Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-13
- Terminated
- 2015-04-07
- Firm location
- Northridge, CA, United States
Product description
Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm 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. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.
Reason for recall
Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount.
Data sourced from openFDA. This site is unofficial and independent of the FDA.