Medtronic MiniMed Paradigm Insulin Infusion Pumps recallZ-2544-2014 · Medtronic MiniMed Inc. · initiated Mar 13, 2014
Class II Terminated All recalls posted in August 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic MiniMed Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount.
FDA root cause category: Device Design
What the company is doing
The firm, Medtronic, sent an "IMPORTANT MEDICAL DEVICE SAFETY INFORMATION" letter dated March 13, 2014 to its customers. The letter described the product, problem and actions to be taken. The letter informs the customers that because accidental button pressing errors may occur it is important that customers always confirm the insulin dose flashing on the display is correct before pressing ACT to start delivery. The letter informs the customers of what safety settings will minimize the risk of an accidental programming error and what actions to be taken. Should you have any questions about this letter or concerns with your keypad, please do not hesitate to contact the 24 hour helpline at (866) 222-7304 for a replacement.
Recall details
- Recall number
- Z-2544-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 13, 2014
- Posted by the FDA
- Aug 22, 2014
- Recalling firm
- Medtronic MiniMed Inc.
- Quantity
- 559,374 units total (444,374 units in US)
- Product code
- OYC
- FDA submissions
- P980022, P120010
- Distribution
- Worldwide Distribution-Nationwide in US
Product description
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.
Code information (models, lots, serial numbers)
Paradigm: MMT-523NAB, MMT-723KNB, MMT-523NAH, MMT-723KNH, MMT -523NAL, MMT-723KNL, MMT-523NAP, MMT-723KNP, MMT-523NAS, MMT-723KNS, MMT-723NAB, MMT-723NAH, MMT-723NAL, MMT-723NAP, MMT-723NAS, MMT-523KNB, MMT-523KNH, MMT-523KNL, MMT-523KNP, MMT-523KNS. MiniMed 530G: MMT-551NAM, MMT-551NAH, MMT-551NAL, MMT-551NAP, MMT-551NAS, MMT-751NAB, MMT-751NAH, MMT-751NAL, MMT-751NAP, MMT-751NAS.
Other devices under the same FDA submission
353 devices cleared under P980022, P120010 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MiniMed® 530G MMT-751NASMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend36 deaths7,479 reports
- Paradigm® REAL-Time Revel™ MMT-723NASMedtronic Minimed, Inc. · Sensor, glucose, invasive15 deaths3,413 reports
- MiniMed® 530G MMT-751NALMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend15 deaths3,405 reports
- MiniMed® 530G MMT-751LNASMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend1 recall7 deaths3,201 reports
- Paradigm® REAL-Time Revel™ MMT-723LNASMedtronic Minimed, Inc. · Sensor, glucose, invasive1 recall12 deaths2,995 reports
- Paradigm® REAL-Time Revel™ MMT-723LNASMedtronic Minimed, Inc. · Sensor, glucose, invasive1 recall18 deaths2,909 reports
- MiniMed® 530G MMT-551NASMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend5 deaths2,944 reports
- MiniMed® 530G MMT-751NABMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend11 deaths2,700 reports
- MiniMed® 530G MMT-751NAPMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend12 deaths2,637 reports
- Paradigm® REAL-Time Revel™ MMT-723LNASMedtronic Minimed, Inc. · Sensor, glucose, invasive1 recall23 deaths2,570 reports
- MiniMed® 530G MMT-751LNASMedtronic Minimed, Inc. · Automated insulin dosing , threshold suspend1 recall2 deaths2,218 reports
- MiniMed® 530G MMT-751NASMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend16 deaths1,995 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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