Device product

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

Z-0109-2018

September 10, 2017

Class II

Product summary

Firm: Medtronic Inc.
Event: Event 78125
Status: Ongoing
Classification: Class II
Quantity: 2,163,610 units
Official record key: device-enforcement:Z-0109-2018

Official wording

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

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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