Pump, Infusion, Insulin
FDA product code LZG · Class II (moderate risk) · 21 CFR 880.5725 · General Hospital
85510(k) clearances
0PMA approvals
64recalls
Manufacturers
- Medtronic Minimed 15
- Insulet Corporation 13
- Disetronic Medical Systems 10
- Tandem Diabetes Care, Inc. 7
- Animas Corporation 7
- Sooil Development Co., Ltd. 3
- Nipro Diabetes Systems, Inc. 3
- Roche Diagnostics Corp. 3
- Abbott Diabetes Care, Inc. 3
- Modular Medical, Inc. 3
- Asante Solutions, Inc. 2
- Minimed, Inc. 2
- Valeritas, Incorporated 2
- Smiths Medical MD, Inc. 2
- Medingo , Ltd. 2
- Pharma-Plast USA, Inc. 1
- Nilimedix , Ltd. 1
- Biovalve Technologies, Inc. 1
- Cardiac Pacemakers, Inc. 1
- Deltec, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262153 | Pivot Insulin Delivery SystemLZG · Traditional | Modular Medical, Inc. | 09/02/2026SE |
| K253534 | Pivot Insulin Delivery SystemLZG · Traditional | Modular Medical | 04/08/2026SE |
| K240158 | Modular Medical MODD1 Insulin Delivery SystemLZG · Traditional | Modular Medical, Inc. | 09/04/2024SE |
| K241622 | Extended Reservoir; MiniMed ReservoirLZG · Special | Medtronic Minimed | 07/02/2024SE |
| K223372 | Omnipod GO Insulin Delivery DeviceLZG · Traditional | Insulet Corporation | 04/24/2023SE |
| K210714 | Extended ReservoirLZG · Traditional | Medtronic Minimed, Inc. | 04/06/2022SE |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemLZG · Traditional | Insulet Corporation | 08/13/2021SE |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 10/21/2019SE |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 01/08/2019SE |
| K180045 | Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 06/01/2018SE |
| K162296 | OmniPod Insulin Management SystemLZG · Traditional | Insulet Corporation | 04/18/2017SE |
| K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterLZG · Traditional | Tandem Diabetes Care, Inc. | 10/25/2016SE |
| K160056 | t:slim Insulin Delivery SystemLZG · Traditional | Tandem Diabetes Care, Inc. | 07/25/2016SE |
| K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterLZG · Traditional | Tandem Diabetes Care, Inc. | 07/13/2016SE |
| K160252 | OmniPod Insulin Management SystemLZG · Traditional | Insulet Corporation | 04/27/2016SE |
| K143189 | t:flex Insulin Delivery SystemLZG · Traditional | Tandem Diabetes Care, Inc. | 01/09/2015SE |
| K142619 | Snap Insulin Pump SystemLZG · Special | Asante Solutions, Inc. | 12/18/2014SE |
| K140439 | Omnipod Insulin Management SystemLZG · Traditional | Insulet Corporation | 11/13/2014SE |
| K141758 | T:Slim Insulin Delivery SystemLZG · Traditional | Tandem Diabetes Care, Inc. | 10/31/2014SE |
| K133593 | T:Slim Insulin Delivery SystemLZG · Special | Tandem Diabetes Care, Inc. | 03/24/2014SE |
| K131294 | Omnipod Insulin Management SystemLZG · Traditional | Insulet Corporation | 08/29/2013SE |
| K122483 | Pearl Diabetes Management SystemLZG · Special | Asante Solutions, Inc. | 01/03/2013SE |
| K122953 | Omnipod Insulin Managment SystemLZG · Traditional | Insulet Corporation | 12/07/2012SE |
| K111353 | Accu-Check Combo SystemLZG · Abbreviated | Roche Diagnostics | 07/17/2012SE |
| K120206 | Medtronic Minimed Paradigm Insulin PumpsLZG · Special | Medtronic Minimed | 03/29/2012SE |
| K111669 | Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management SystemsLZG · Traditional | Insulet Corporation | 12/15/2011SE |
| K111210 | T:Slim (TM) Insulin Delivery SystemLZG · Traditional | Tandem Diabetes Care, Inc. | 11/09/2011SE |
| K100567 | Pearl Diabetes Management SystemLZG · Traditional | M2 Group Holdings, Inc. | 05/10/2011SE |
| K103825 | V-Go Insulin Delivery SystemLZG · Traditional | Valeritas, Inc. | 02/23/2011SE |
| K100504 | V-Go Disposable Insulin Delivery Device, Model# V-Go 20, V-Go 30, V-GO40LZG · Traditional | Valeritas, LLC | 12/01/2010SE |
| K093364 | Solo Micropump Insulin Delivery SystemLZG · Traditional | Medingo , Ltd. | 01/25/2010SE |
| K090245 | Solo Insulin Patch PumpLZG · Traditional | Medingo , Ltd. | 07/23/2009SE |
| K083225 | Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemLZG · Traditional | Abbott Diabetes Care, Inc. | 02/20/2009SE |
| K082590 | Symphony Meter RemoteLZG · Traditional | Lifescan, Inc. | 12/17/2008SE |
| K082595 | Modification To:Accu-Chek Pocket Compass Diabetes Management SoftwareLZG · Special | Roche Diagnostics | 10/28/2008SE |
| K080639 | Symphony Glucose Management SystemLZG · Traditional | Animas Corp. | 06/24/2008SE |
| K070844 | Nilimedix AdiLZG · Traditional | Nilimedix , Ltd. | 06/06/2008SE |
| K073356 | Paradigm Insulin Infusion Pump, Models MMT-512, MMT-712, MMT-515 and MMT-715LZG · Special | Medtronic Minimed | 04/25/2008SE |
| K071788 | Aviator Insulin PumpLZG · Traditional | Abbott Diabetes Care, Inc. | 01/11/2008SE |
| K071613 | Amigo Insulin PumpLZG · Traditional | Nipro Diabetes Systems, Inc. | 12/14/2007SE |
| K063674 | Ezmanager Max Diabetes Management SoftwareLZG · Traditional | Animas Corp. | 03/30/2007SE |
| K063126 | Dana Diabecare IisLZG · Special | Sooil Development Co., Ltd. | 02/02/2007SE |
| K062323 | Deltec Cozmo Insulin Infusion Pump with Cozmonitor Blood Glucose Meter, Models 21-1815…LZG · Special | Smiths Medical MD, Inc. | 11/01/2006SE |
| K060876 | Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek…LZG · Traditional | Disetronic Medical Systems AG | 06/15/2006SE |
| K053177 | Medtronic Minimed Paradigm Insulin Pump, Model MMT-712ELZG · Traditional | Medtronic Minimed | 01/31/2006SE |
| K051041 | Insulin PumpLZG · Traditional | Abbott Diabetes Care, Inc. | 12/23/2005SE |
| K050760 | Accu-Chek Pocket Compass Diabetes Management SoftwareLZG · Traditional | Roche Diagnostics Corp. | 09/13/2005SE |
| K050971 | Biovalve Insulin Delivery Systems (Bids)LZG · Traditional | Biovalve Technologies, Inc. | 08/16/2005SE |
| K050312 | Amigo Insulin PumpLZG · Traditional | Nipro Diabetes Systems, Inc. | 05/09/2005SE |
| K042887 | Accu-Chek SpiritLZG · Traditional | Disetronic Medical Systems AG | 03/18/2005SE |
| K042792 | Ixl-Ii Diabetes Management SystemLZG · Traditional | Insulet Corporation | 01/03/2005SE |
| K042873 | Animas Model IR1250 Insulin Infusion PumpLZG · Traditional | Animas Corp. | 12/10/2004SE |
| K043000 | Modification to D-TronplusLZG · Special | Disetronic Medical Systems AG | 12/01/2004SE |
| K041318 | Medtronic Minimed Paradigm Model 511 Insulin PumpLZG · Special | Medtronic Minimed | 07/19/2004SE |
| K041317 | Modification to Medtronic Minimed Paradigm Model 512 Insulin PumpLZG · Special | Medtronic Minimed | 07/19/2004SE |
| K031738 | Smiths Medical Insulin Infusion Pump with Cozmonitor Glucose MeterLZG · Traditional | Smiths Medical MD, Inc. | 05/27/2004SE |
| K040676 | Medtronic Minimed Paradigm Insulin Pump, Models MMT-515 and MMT-715LZG · Traditional | Medtronic Minimed | 05/21/2004SE |
| K031373 | Ixl Diabetes Management SystemLZG · Traditional | Insulet Corp. | 12/19/2003SE |
| K031541 | Paradigmpal, Model MMT-7330LZG · Traditional | Minimed, Inc. | 11/18/2003SE |
| K032164 | Diabetes Data Management System (DDMS), Model 7333LZG · Traditional | Medtronic Minimed | 10/23/2003SE |
| K032257 | Model Ir 1200 Insulin PumpLZG · Traditional | Animas Corp. | 10/16/2003SE |
| K030531 | Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose MeterLZG · Traditional | Minimed, Inc. | 06/17/2003SE |
| K022394 | Ezmanager PlusLZG · Traditional | Animas Corp. | 06/05/2003SE |
| K023471 | Disetronic H-Tronplus Insulin Infusion PumpLZG · Special | Disetronic Medical Systems AG | 10/29/2002SE |
| K022831 | Modification to Disetronic D-Tronplus Insulin Infusion PumpLZG · Special | Disetronic Medical Systems AG | 09/11/2002SE |
| K020655 | Deltec Insulin Infusion Pump and AccessoriesLZG · Traditional | Deltec, Inc. | 08/13/2002SE |
| K022317 | Dana Diabecare II Insulin Pump & Superline-Easyrelease, Soft-Release-St, &…LZG · Special | Sooil Development Co., Ltd. | 08/02/2002SE |
| K021725 | Disetronic D-Tron Insulin Infusion PumpLZG · Special | Disetronic Medical Systems AG | 08/02/2002SE |
| K013309 | Glucopro Evo Infusion PumpLZG · Traditional | Nipro Diabetes Systems, Inc. | 06/24/2002SE |
| K021439 | Model R1000 Ir Insulin Pump, Ezlink Software, Sermon Software, R1000 Ir Download Cradle…LZG · Special | Animas Corp. | 05/29/2002SE |
| K013807 | Microjet Quark, Model U100 or U40LZG · Traditional | Cane S.R.L. | 12/12/2001SE |
| K001604 | Dana DiabecareLZG · Traditional | Sooil Development Co., Ltd. | 08/14/2000SE |
| K993184 | R1000 Series Insulin PumpLZG · Traditional | Animas Corp. | 02/10/2000SE |
| K994186 | Disetronic D-Tron Insulin Infusion PumpLZG · Special | Disetronic Medical Systems | 12/30/1999SE |
| K993012 | Minimed Com-Station, HARDWARE-7301; SOFTWARE-7311LZG · Traditional | Medtronic Minimed | 11/15/1999ST |
| K991376 | Dahedi Insulin Infusion PumpLZG · Traditional | Disetronic Medical Systems | 06/15/1999SE |
| K990801 | Minimed 508 Insulin PumpLZG · Traditional | Medtronic Minimed | 06/08/1999ST |
| K973044 | Disetronic H-Tron Plus V 100 Insulin Infusion PumpLZG · Traditional | Disetronic Medical Systems | 09/15/1997ST |
| K972107 | Minimed Infusion Pump, Model 507CLZG · Traditional | Medtronic Minimed | 08/15/1997ST |
| K963948 | Minimed Insulin Pump, Model 505LZG · Traditional | Medtronic Minimed | 04/08/1997ST |
| K960001 | Minimed Infusion Pump, Model MMT-507LZG · Traditional | Medtronic Minimed | 04/30/1996ST |
| K905693 | H-Tron V 100 Insulin Infusion PumpLZG · Traditional | Disetronic Medical Systems | 04/12/1991SE |
| K901588 | Minimed(R) Model 506 External Insulin PumpLZG · Traditional | Medtronic Minimed | 07/02/1990SE |
| K900498 | Modified Betatron IV Insulin Infusion SystemLZG · Traditional | Cardiac Pacemakers, Inc. | 02/23/1990SE |
| K884978 | Pharma-Plast Insulin Infusion SetLZG · Traditional | Pharma-Plast USA, Inc. | 06/21/1989SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2605-2026 Class I | Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD-…External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of… | Insulet Corporation | 05/20/2026Open, Classified |
| Z-2604-2026 Class I | Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack)…External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of… | Insulet Corporation | 05/20/2026Open, Classified |
| Z-1748-2026 Class II | Paradigm Insulin Pump (MMT-712, MMT-715)All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be… | Medtronic MiniMed, Inc. | 02/13/2026Open, Classified |
| Z-1255-2025 Class II | Paradigm REF: MMT-712 and MMT-715All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have… | Medtronic MiniMed, Inc. | 01/31/2025Open, Classified |
| Z-0154-2023 Class I | 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final…The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery… | Insulet Corporation | 10/17/2022Terminated |
| Z-2351-2021 Class II | Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers:…Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test… | Roche Diabetes Care, Inc. | 07/28/2021Open, Classified |
| Z-1203-2021 Class II | Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT…Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and… | Insulet Corporation | 02/01/2021Terminated |
| Z-2165-2020 Class II | Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011…After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the… | Insulet Corporation | 04/02/2020Terminated |
| Z-2164-2020 Class II | Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010…After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the… | Insulet Corporation | 04/02/2020Terminated |
| Z-1553-2020 Class II | Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D:…In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose… | Insulet Corporation | 02/13/2020Terminated |
| Z-0199-2020 Class II | DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02There is a potential for "No Needle Demo Units" to contain a needle. | Valeritas, Incorporated | 07/03/2019Terminated |
| Z-0198-2020 Class II | DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03There is a potential for "No Needle Demo Units" to contain a needle. | Valeritas, Incorporated | 07/03/2019Terminated |
| Z-0197-2020 Class II | DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01There is a potential for "No Needle Demo Units" to contain a needle. | Valeritas, Incorporated | 07/03/2019Terminated |
| Z-0196-2020 Class II | DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02There is a potential for "No Needle Demo Units" to contain a needle. | Valeritas, Incorporated | 07/03/2019Terminated |
| Z-0195-2020 Class II | DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03There is a potential for "No Needle Demo Units" to contain a needle. | Valeritas, Incorporated | 07/03/2019Terminated |
| Z-1586-2020 Class II | Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | Medtronic MiniMed | 06/27/2019Open, Classified |
| Z-1585-2020 Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-712EThe action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | Medtronic MiniMed | 06/27/2019Open, Classified |
| Z-1584-2020 Class II | MiniMed Paradigm Insulin pump, model number MMT-712The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | Medtronic MiniMed | 06/27/2019Open, Classified |
| Z-1583-2020 Class II | MiniMed Paradigm 512 Insulin pumpThe action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | Medtronic MiniMed | 06/27/2019Open, Classified |
| Z-1582-2020 Class II | MiniMed Paradigm Model 511 Insulin PumpThe action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | Medtronic MiniMed | 06/27/2019Open, Classified |
| Z-1581-2020 Class II | MiniMed Insulin Pump, model # MMT-508The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | Medtronic MiniMed | 06/27/2019Open, Classified |
| Z-0347-2020 Class II | Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001…There is a potential for a communication interruption following a bolus command that may result in… | Insulet Corporation | 12/18/2018Terminated |
| Z-0178-2020 Class I | Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use…There is a potential security vulnerability related to the use of the remote controller accessories with the… | Medtronic Inc. | 08/07/2018Terminated |
| Z-0177-2020 Class I | Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE…There is a potential security vulnerability related to the use of the remote controller accessories with the… | Medtronic Inc. | 08/07/2018Terminated |
| Z-0394-2016 Class I | OmniPod, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The…Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. | Insulet Corporation | 11/02/2015Terminated |
| Z-0393-2016 Class I | OmniPod, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The…Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. | Insulet Corporation | 11/02/2015Terminated |
| Z-2749-2015 Class II | Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and…Punctured blister packages were detected during the packaging process at the manufacturing site. Potential… | Elcam Medical, Inc. | 07/19/2015Terminated |
| Z-2748-2015 Class II | Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for…Punctured blister packages were detected during the packaging process at the manufacturing site. Potential… | Elcam Medical, Inc. | 07/19/2015Terminated |
| Z-2485-2015 Class I | OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog…OmniPods (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be… | Insulet Corporation | 07/13/2015Terminated |
| Z-2484-2015 Class I | OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog…OmniPods (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be… | Insulet Corporation | 07/13/2015Terminated |
| Z-1734-2015 Class II | AccuChek Spirit insulin infusion pump.Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek… | Roche Diabetes Care, Inc. | 04/22/2015Terminated |
| Z-1733-2015 Class II | AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek… | Roche Diabetes Care, Inc. | 04/22/2015Terminated |
| Z-1228-2015 Class III | CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application…The firm is informing customers of a software error that might result in an inaccurate display of the Temp… | Medtronic MiniMed Inc. | 11/10/2014Terminated |
| Z-0146-2015 Class II | ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System…The insulin pump may lose time and date settings during a power interruption (such as a battery change) due… | Roche Diagnostics Operations, Inc. | 09/25/2014Terminated |
| Z-0827-2014 Class I | T:slim Insulin Delivery System Insulin Infusion PumpSpecific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A… | Tandem Diabetes Care Inc | 01/10/2014Terminated |
| Z-0166-2014 Class II | OmniPod Insulin Management Product Demonstration Kit; Model Reference Number:…Alcohol Prep Pads contained within the kit are not properly labeled. | Insulet Corporation | 09/27/2013Terminated |
| Z-0165-2014 Class II | OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400…Alcohol Prep Pads contained within the kit are not properly labeled. | Insulet Corporation | 09/27/2013Terminated |
| Z-0993-2013 Class I | Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for…Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The… | Animas Corporation | 01/03/2013Terminated |
| Z-0836-2013 Class III | Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps…Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1… | Animas Corporation | 12/17/2012Terminated |
| Z-0137-2015 Class II | Animas Vibe Insulin Infusion Pump and System. These products are indicated for…Animas determined that keypad wear over time was contributing to an increased complaint rate associated with… | Animas Corporation | 10/25/2012Terminated |
| Z-0005-2013 Class II | IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose…Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump. | Animas Corporation | 07/16/2012Terminated |
| Z-1376-2012 | OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to…There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to… | Animas Corporation | 03/01/2012Terminated |
| Z-3017-2011 | Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion.Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of… | Animas Corporation | 07/29/2011Terminated |
| Z-1678-2011 | 2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusionAction is being undertaken to address the occurrence of adverse events associated with leaking cartridges.… | Animas Corporation | 02/25/2011Terminated |
| Z-2397-2010 | Animas IR 1250 (1200 plus) Intended use:deliver insulin therapysensor could be damaged | Animas Corporation | 03/18/2010Terminated |
| Z-2396-2010 | Animas IR 1200 Intended use:deliver insulin therapysensor could be damaged | Animas Corporation | 03/18/2010Terminated |
| Z-2395-2010 | Animas 2020 Insulin Infusion Pumps Intended use:deliver insulin therapysensor could be damaged | Animas Corporation | 03/18/2010Terminated |
| Z-2394-2010 | One Touch Ping Glucose Management Systems Intended use: deliver insulin therapysensor could be damaged | Animas Corporation | 03/18/2010Terminated |
| Z-1560-2010 | One Touch Ping Insulin Pump using ezManager Max diabetes management softwareSoftware malfunction which disallows users to download, view and print information from their pump… | Animas Corporation | 12/18/2009Terminated |
| Z-1646-2009 | Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001.The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional… | Disetronic Medical Systems, Inc. | 04/30/2009Terminated |