Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715,

FDA device recall Z-1085-2013 · posted 2013-04-10 · Terminated

Recall details

Recalling firm

Medtronic MiniMed

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.

Action taken

Medtronic 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). Distributors are instructed to provide Medtronic with an Excel spreadsheet list of all end users to whom they have shipped any of the listed serialized products.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

OYC

Quantity 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,

Date initiated

2013-03-22

Date posted

2013-04-10

Date terminated

2013-11-04

Location

Northridge, CA