PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 17, 2013 Initiated: March 22, 2013 #Z-1085-2013

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.

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.

Details

Recalling Firm
Medtronic MiniMed
Units Affected
428,000 units
Distribution
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.
Location
Northridge, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Medtronic MiniMed. Units affected: 428,000 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2013. Severity: Moderate. Recall number: Z-1085-2013.

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