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MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714… recallZ-0001-2025 · Medtronic MiniMed, Inc. · initiated Jul 31, 2024

Class I Open, Classified All recalls posted in October 2024

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

FDA root cause category: Device Design

What the company is doing

On 7/31/24, Safety Alert notices were sent to customers, healthcare professionals, distributors who were told the following: 1) Always pay attention to alerts and alarms displayed on your pump. - Low Battery Pump alert will display when your pump has up to 10 hours of battery life left. - Replace Battery alert will display when the pump has less than 30 minutes of battery life left. If the battery is not replaced within 10 minutes, a siren will sound and repeat once every minute until the Replace Battery Now alarm is displayed. At that time, the pump will stop insulin delivery. If the battery is not replaced within 10 minutes of this alarm, a siren will sound, and the pump will shut down. 2) If your pump has been dropped, bumped, or has experienced physical impact, pay special attention to any pump alerts and alarms, including low battery alerts, as they may occur earlier than expected. 3) Pump's battery level is on the status bar located on the pump home screen. 4) Refer to the pump user guide for instructions on how to replace the battery. 5) If you notice any significant changes in battery life or need additional troubleshooting assistance, the firm's Technical Support line for further help. 6) Always have extra new AA lithium or alkaline batteries or fully charged NiMH batteries available, along with your other emergency kit supplies. 7) Complete and return the confirmation form by visiting https://info.medtronicdiabetes.com/battery-statusacknowledgement In addition, distribution partners and service providers were provided with a patient letter they could use to inform customers/pump users. If you have further questions or need assistance, please call the firm's 24-Hour Technical Support line at 800-646-4633, option 1.

Recall details

Recall number
Z-0001-2025
Recall class
Class I (most serious)
Status
Open, Classified
Initiated by the company
Jul 31, 2024
Posted by the FDA
Oct 3, 2024
Recalling firm
Medtronic MiniMed, Inc.
Quantity
24,595
Product code
OZO
FDA submissions
P150001
Distribution
US: CT, MI, PA, WA, IA, NY, ND, AZ, TX, OH, NC, AL, MN, IN, NJ, KY, UT, CA, FL, VA, MS, NM, NV, TN, GA, MA, NH, OK, VT, IL, ME, SC, LA, WY, RI, SD, KS, WI, MD, CO, DE, AR, AK, ID, MO, NE, WV, MT, OR, DC, HI, VI, PR. OUS: Worldwide

Product description

MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

REF/UDI-DI(GTIN): MMT-1714/00643169782396, 00763000253059; MMT-1715/00643169873841, 00763000190446, 00643169752726, 643169873834, 00763000317591, 00763000316655, 763000367053, 763000316655, 76300031665503, 763000190439, 763000316631, 763000166519, 763000072520, 76300031665501, 763000256807, 763000090197, 643169656840, 763000316686, 00643169656840, 00763000090197, 00763000190439, 00763000316631; MMT-1755/643169752726, 643169873841, 763000190446, 763000101527, 763000317591, 00763000317591, 763000367091, 763000179632, 763000317621, 643169878648, 763000157043, 76300031759103, 00643169752726, 76300031759101, 76300031762103, 76300031762101, 00763000101527, 00763000190446; MMT-1801/00763000531157; MMT-1805/00763000561680; MMT-1850/00763000552541; MMT-1851/00763000854737, 00763000541323. All serial numbers.

Devices named in this recall

21 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

18 devices cleared under P150001 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95121).

Sources and updates

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