The Recall Desk
HighFDA (Devices)·Z-0109-2018·Announced 2017-11-29

Medtronic MiniMed Sure-T Infusion Sets Recalled for Insulin Over-Delivery Risk

Medtronic is recalling Sure-T infusion sets because they may deliver too much insulin. This could cause low blood sugar in patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of harm (insulin over-delivery leading to hypoglycemia) where specific injury reports are not detailed in the source text, fitting the 'High' criteria for risk-of-harm products.

Plain-English summary

Medtronic Inc. is recalling Medtronic MiniMed(TM) Sure-T(TM) infusion sets due to a potential for over-delivery of insulin. The recall affects 2,163,610 units distributed worldwide.

The specific hazard identified is that the infusion sets have the potential to deliver more insulin than intended. This over-delivery can lead to hypoglycemia, or low blood sugar, in patients using the devices.

Patients using these specific infusion sets should contact their healthcare provider or Medtronic for instructions on how to proceed. The recall number is Z-0109-2018.

The recalled product

Product
Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
Manufacturer
Medtronic Inc.
Category
Medical Device — Insulin Infusion Set
Hazard
Affected units
2,163,610

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 recalled by Medtronic Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Medtronic Inc.

See all →

Same hazard · insulin over delivery

See all →