Medtronic recalls specific MiniMed 630G System models with SmartGuard due to potential loose reservoir causing insulin delivery issues. Affected units may lead to hypoglycemia or hyperglycemia.
There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.
Medtronic is recalling certain MiniMed 630G System devices with SmartGuard because a loose reservoir can cause improper insulin delivery, risking low or high blood sugar levels.
A broken or missing retainer ring can cause the insulin reservoir to become loose in the pump. This may lead to over or under delivery of insulin, causing blood sugar levels to drop too low (hypoglycemia) or rise too high (hyperglycemia).
People with diabetes using the recalled MiniMed 630G System devices are affected. Those with insulin pumps that have black retainer rings are not affected.
Check for the model numbers MMT-1515, MMT-1715, MMT-1714, MMT-1754, or MMT-1755 on the device. Devices with black retainer rings are not affected.
Ensure the reservoir is securely locked into the pump by pressing the side of the reservoir against the pump until it clicks. If it doesn't click, the reservoir may be loose.
Reach out to Medtronic for guidance on whether your device needs repair or replacement.
The recall is due to reported incidents of a loose reservoir that can no longer be locked into the pump, which may cause improper insulin delivery.
No, devices with black retainer rings are not affected by this recall.
Ensure the reservoir is securely locked into the pump by pressing the side until it clicks. If it doesn't click, contact Medtronic for assistance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0955-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0955-2020 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
