FDAClass IIApril 17, 2013

Medtronic MiniMed Paradigm Insulin Infusion Pumps recall

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…

Why was Medtronic MiniMed Paradigm Insulin Infusion Pumps 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Not available

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…
Recalling firm
Medtronic MiniMed
Quantity
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.
Recall date
April 17, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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