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

MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T recalled

Medtronic is recalling MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T. 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: 5179979 5182542 5185471 5187173 5188894 5189581 5191349 5192467 5178077 5189588 5181137 5181140 5184757 5184758 5186199 5186203 5188890 5191350 5193510 5186206 5179854 5179857 5179975 5181712 5182176 5182543 5183121 5185154 5185157 5186200 5186201 5186202 5187102 5187170 5188889 5188893 5190033 5190708 5190710 5191351 5192470 5192679 5194101 5168207 5189592 5175824 5176442 5179855 5179977 5181711 5181713 5182177 5182179 5182544 5183122 5183123 5184087 5185155 5185156 5187101 5187171 5187817 5188886 5188887 5188888 5188895 5189583 5189584 5189585 5189586 5190031 5190707 5190709 5192468 5192469 5192471 5192680 5192691 5192692 5193308 5194100 5178081 5185473 5186207 5187821 5189590 5191354 5178084 5183072 5185153 5187103 5187818 5187819 5187820 5188892 5193505 5178076 5189591 5175953 5181138 5185472 5187172 5191352 5192682 5186205 5181139 5186204 5189587

Quantity recalled1,898,570 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-0108-2018
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) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

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: 5179979 5182542 5185471 5187173 5188894 5189581 5191349 5192467 5178077 5189588 5181137 5181140 5184757 5184758 5186199 5186203 5188890 5191350 5193510 5186206 5179854 5179857 5179975 5181712 5182176 5182543 5183121 5185154 5185157 5186200 5186201 5186202 5187102 5187170 5188889 5188893 5190033 5190708 5190710 5191351 5192470 5192679 5194101 5168207 5189592 5175824 5176442 5179855 5179977 5181711 5181713 5182177 5182179 5182544 5183122 5183123 5184087 5185155 5185156 5187101 5187171 5187817 5188886 5188887 5188888 5188895 5189583 5189584 5189585 5189586 5190031 5190707 5190709 5192468 5192469 5192471 5192680 5192691 5192692 5193308 5194100 5178081 5185473 5186207 5187821 5189590 5191354 5178084 5183072 5185153 5187103 5187818 5187819 5187820 5188892 5193505 5178076 5189591 5175953 5181138 5185472 5187172 5191352 5192682 5186205 5181139 5186204 5189587

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