ClearanceBrief
Recall Z-1085-2013 ยท OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Medtronic MiniMed

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 intended for use to deliver basal and bolus insulin to persons with diabetes.

DateApr 10, 2013 (initiated Mar 22, 2013)
StatusTerminated
ReasonMedtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap may become detached from the pump case and protrude from the lower right side of the pump. When the pump is expose to water it 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.
Root causeNonconforming Material/Component
ActionMedtronic sent an Urgent Medical Device Safety Notification letters to all affected customers. The recall letter informs the customers of the problem identified and the actions to be taken. The letter informs the healthcare professionals that Medtronic will inform their patients about the potential safety issues. Customers are instructed to find online information at www.medtronicdiabetes.com/support/product-updates. Customers are instructed to call Medtronic at 1.888.204.7616 (option 1 for loose drive support cap related questions and option 2 for water damage related questions). Distrib
Quantity428,000 units
DistributionWorldwide Distribution - USA (nationwide) the countries of: AE, AR, AT, AU, BA, BH, BM, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, LC, LV, MK, MX, MY, NL, NO, NZ, OM, PA, PE, PL, PR, PY, QA, RO, SA
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.