Medtronic Inc.: Medical Device Recall in 2017 - (Recall #: Z-0109-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)

Product Classification:

Class II

Date Initiated: September 10, 2017

Date Posted: November 29, 2017

Recall Number: Z-0109-2018

Event ID: 78125

Reason for Recall:

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

Status: Ongoing

Product Quantity: 2,163,610 units

Code Information:

Lot Numbers: 5188321 5190185 5190186 5184968 5185467 5185468 5185469 5185470 5188322 5188323 5188324 5188325 5188326 5188327 5188328 5189476 5189477 5189478 5189521 5189522 5190187 5190188 5190189 5191046 5191047 5191355 5192532 5183060 5183061 5187300 5187301 5187556 5187557 5189051 5193052 5188329 5188330 5189053 5189054 5194937 5185690 5187558 5191357 5187559

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated