CLASS II ONGOING Device recall · Reported 29 Nov 2017 · FDA Enforcement Report

MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T recalled

Medtronic is recalling MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884. The recall was initiated on 10 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled2,163,610 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0109-2018
FDA event ID: 78125
Recalling firm: Medtronic, Northridge, CA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Sep 2017
FDA classified: 18 Nov 2017
Reported: 29 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Sep 2017	Recall initiated by company
18 Nov 2017	Classified by FDA	+69 days
29 Nov 2017	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Worldwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 78125

This product is part of a recall event; the main page for the event is MiniMed(TM) Pro-set(TM) (MMT-280, 281) recalled by Medtronic.

Reported	Class	Recall	Company	Reason	Where
29 Nov 2017	CLASS II	MiniMed(TM) Pro-set(TM) (MMT-280, 281) recalled by Medtronic	Medtronic	Other	CA
29 Nov 2017	CLASS II	MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T recalled	Medtronic	Other	CA
29 Nov 2017	CLASS II	MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T recalled	Medtronic	Other	CA
29 Nov 2017	CLASS II	MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T recalled	Medtronic	Other	CA

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