Paradigm®
Pump MMT-715LNAS Rohs Prdgm 2.3 SK EN LN
7manufacturers in China registered for this device type
1catalogue number
15510(k) clearances naming this product code
19recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (3), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Viant Medical Suzhou EPZ Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Medtronic Minimed, United States |
|---|---|
| FDA product code | LZG |
| Device type | Pump, Infusion, Insulin |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K040676 |
| Record published | 2020-11-16 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MMT-715LNAS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OneTouch Ping | Animas Corp. | 12 |
| Easy Release | Sooil Development Co., Ltd. | 9 |
| V-Go Disposable Insulin Delivery | Mannkind Corporation | 6 |
| Accu-Chek Combo | Roche Diabetes Care, Inc. | 5 |
| Superline | Sooil Development Co., Ltd. | 4 |
| t:slim Cartridge, t:lock, 10 Pack | Tandem Diabetes Care, Inc. | 3 |
| Dana Diabecare | Sooil Development Co., Ltd. | 3 |
| Accu-Chek Spirit Cartridge | Roche Diabetes Care, Inc. | 2 |
| t:slim X2 Insulin Pump | Tandem Diabetes Care, Inc. | 2 |
| Omnipod | Insulet Corporation | 2 |
| Soft-Release-ST | Sooil Development Co., Ltd. | 2 |
| t:slim Insulin Pump, Replacement | Tandem Diabetes Care, Inc. | 1 |
Showing 12 of 53. All products under Pump, Infusion, Insulin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241622 | 2024-07-02 |
| K210714 | 2022-04-06 |
| K120206 | 2012-03-29 |
| K073356 | 2008-04-25 |
| K053177 | 2006-01-31 |
| K041318 | 2004-07-19 |
| K041317 | 2004-07-19 |
| K040676 | 2004-05-21 |
| K032164 | 2003-10-23 |
| K993012 | 1999-11-15 |
| K990801 | 1999-06-08 |
| K972107 | 1997-08-15 |
| K963948 | 1997-04-08 |
| K960001 | 1996-04-30 |
| K901588 | 1990-07-02 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Minimed | 510(k) number | 2026-02-13 | Class II | Device Design | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectiv | 73,656 | |
| Medtronic Minimed | 510(k) number | 2007-04-27 | Not classified | Other | Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some | 334,000 Paradigm insulin pumps (approx) | 2012-09-19 |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-01-31 | Class II | Device Design | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. | 20,760 units | |
| 2019-06-27 | Class II | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirel | 73,028 | |
| 2019-06-27 | Class II | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirel | 30,479 | |
| 2019-06-27 | Class II | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirel | 34,777 | |
| 2019-06-27 | Class II | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirel | 64,174 units | |
| 2019-06-27 | Class II | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirel | 74,496 | |
| 2019-06-27 | Class II | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirel | 36,143 | |
| 2018-08-07 | Class I | Software design | There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps. | 90,213 | 2024-03-29 |
| 2018-08-07 | Class I | Software design | There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps. | 141,519 | 2024-03-29 |
| 2014-11-10 | Class III | Software design | The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded from the MiniMed 620G or 640G insulin pump. | 5 CareLink Pro 4.0 CD ROMs | 2015-03-10 |
| 2005-04-27 | Not classified | Other | The text description of how to perform insulin sensitivity testing and associated worksheet included in the booklet that is shipped with the Paradigm 515 and Paradigm 715 insulin pumps contained a basic flaw in that the blood glucose after | Approximately 14,560 | 2007-03-20 |
| 2004-09-14 | Not classified | Other | Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed thi | 10,600 | 2005-03-03 |
| 2004-09-14 | Not classified | Other | Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed thi | 2005-03-03 | |
| 2004-01-28 | Not classified | Other | A minor software anomaly results in an error in the calculation of the average glucose range that appears on one of the reports available in the model 7311 software. | 2005-01-18 | |
| 2003-11-19 | Not classified | Other | Accessory software fails to report certain reports following download of data from 712 pump. | 1020 | 2005-03-03 |
| 2003-09-09 | Not classified | Other | Non delivery of insulin by pump after electrostatic discharge. | 17,000 | 2005-09-02 |
| 2003-08-29 | Not classified | Other | Water ingresses into the device when in prolonged contact with water causing device to malfunction. | Approximately 61,000 patients | 2005-09-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.