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U.S. Department of Health and Human Services

Enforcement Report - Week of April 17, 2013

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Product Detail

Product Description 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.
Recall Number Z-1085-2013
Classification Class II
Code Info Not available
Product Distributed Qty 428,000 units
Reason For Recall Medtronic 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.

Event Detail

Event Id 64754
Product Type Devices
Status Ongoing
Recalling Firm Medtronic MiniMed
City Northridge
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide 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, SE, SG, SI, SK, SV, SY, TF, TH, TR, TT, TW, UA, UY, VE, ZA.
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