BEUDAMED
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    Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.

    FDA Enforcement
    Class I ·Terminated·Medtronic MiniMed·July 17, 2013

    Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: 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. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.

    FDA Enforcement
    Class II ·Terminated·Medtronic MiniMed Inc.·September 3, 2014

    Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D

    FDA Enforcement
    Class II ·Terminated·Medtronic MiniMed Inc.·August 20, 2014

    Medtronic MiniMed paradigm mio Infusion Sets MMT-921 The Paradigm mio infusion sets are intended for the subcutaneous infusion of insulin from a Medtronic MiniMed Paradigm insulin infusion pum.

    FDA Recall
    Terminated ·Medtronic Minimed·Product code FPA·May 16, 2011

    Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T infusion sets MMT-862, MMT-863, MMT-864, MMT-865, MMT-866, MMT-873, MMT-874, MMTMMT-875, MMT-876, MMT-884, & MMT-886. MiniMed Duo sensor/infusion sets: MMT-5001A23, MMT-5001A43, MMT-5001B23, MMT-5001B43, MMT-5011A23, MMT-5011A43, MMT-5011B23, & MMT-5011B43. Silhouette and Sure-T disposable infusion sets are used with Medtronic insulin infusion pumps using Paradigm P-cap connectors. The infusion set connects the insulin reservoir in the pump to the patients body.

    FDA Enforcement
    Class II ·Terminated·Medtronic MiniMed Inc.·December 17, 2014

    CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory to: - read and store history and settings data supported insulin pump models and supported blood glucose meters - read and report user-programmable settings on supported pump models - read device data from the CareLink Online system - write new device data to the CareLink system - generate reports from the patient records for use in managing the patient's therapy. CareLink Clinical Medtronic CareLink MMT-7334 is a network based software system residing on a computer server platform connected to the Internet. The system is designed to upload patient data from Medtronic MiniMed insulin pumps and supported third-party blood glucose meters to the MMT-7334 central database via a client PC (Personal Computer), which connects to supported devices. The data contained in MMT-7334 is accessible to users using a standard browser, i.e. Microsoft Internet Explorer, on a PC that is connected to the Internet. The user may view and print various reports generated from the device data uploaded to MMT-7334, plus additional information provided by the user. The product does not provide any medical advice to patients or physicians. This is currently only intended to be used in Clinical Trials. Both products are CD ROMs.

    FDA Enforcement
    Class III ·Terminated·Medtronic MiniMed Inc.·March 11, 2015

    Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The information provided by these devices is intended for use in identifying potential episodes of high or low blood glucose. The information provided is not intended to be used directly for making therapy adjustment but rather to assist the user in determining that an additional fingerstick glucose measurement may be appropriate. Per the product labeling, all therapy adjustments should be based on fingerstick glucose measurements obtained using standard home glucose meters and not on the sensor glucose values provided by the Guardian REAL-Time monitor. The CSS7100 and CSS7100K monitors are identical expect for the fact that the CSS7100K monitor is a pediatric version that has a minimum programmable low alert setting of 90 mg/dL. The minimum programmable low glucose alert setting for the adult model (CSS7100) is 40 mg/dL.

    FDA Enforcement
    Class II ·Terminated·Medtronic MiniMed Inc.·August 20, 2014

    Medtronic MiniMed Paradigm Model 712

    FDA Recall
    Terminated ·Medtronic MiniMed·Product code LZG·September 14, 2004

    Medtronic MiniMed Paradigm Model 512

    FDA Recall
    Terminated ·Medtronic MiniMed·Product code LZG·September 14, 2004

    Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically, the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. Product Quantity Distributed (Int) 669,672 units

    FDA Enforcement
    Class II ·Terminated·Medtronic MiniMed·August 28, 2013

    MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.

    FDA Enforcement
    Class II ·Terminated·Medtronic MiniMed Inc.·August 5, 2015

    BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·May 10, 2017

    Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D

    FDA Recall
    Terminated ·Medtronic MiniMed Inc.·Product code FRN·June 16, 2014

    Medtronic MiniMed Model 7311Version 5.0A Solutions Pumps and Meters Software

    FDA Recall
    Terminated ·Medtronic MiniMed·Product code LZG·November 19, 2003

    Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc.·July 11, 2018

    Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software.

    FDA Recall
    Terminated ·Medtronic MiniMed·Product code LZG·January 28, 2004

    Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754

    FDA Recall
    Terminated ·Medtronic Inc.·Product code FPA·April 24, 2018

    ''Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS

    FDA Recall
    Terminated ·Medtronic MiniMed·Product code LZG·April 27, 2005

    Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT359L6; & MMT-359L9. (differences in models is variation in length, 6 versus 9mm)

    FDA Recall
    Terminated ·Medtronic MiniMed·Product code FPA·March 2, 2004

    Paradigm Model 511 and 512 Insulin Infusion Pumps

    FDA Recall
    Terminated ·Medtronic MiniMed·Product code LZG·August 29, 2003