Z-0108-2018Class II

Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T...

Name: Z-0108-2018 Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T...
Creator: Medtronic Inc.
Published: 2017-09-10
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-09-10 / Open, Classified / root cause: design

FDA source

Medtronic Inc. began a recall of Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T) on 2017-09-10. FDA classified it as Class II and gives the reason as "Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0108-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-09-10
Posted: 2017-11-18
Recalling firm: Medtronic, Inc.
Product: Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
Product code: FPA Set, Administration, Intravascular
Reason for recall: Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm initiated its recall on 09/11/2017 by issuing a public notice, following with letters and emails. The firm also employed the use of Facebook and Twitter as well as posting on its website. The recall notice directs the customer to visit https://checklots.medtronicdiabetes.com for information on the lot numbers. Persons with additional questions may call Medtronic at 1.888.204.7616.
Quantity in commerce: 1,898,570 units
Distribution: Worldwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0108-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0107-2018	Class II	Ongoing	Voluntary: Firm initiated	2017-11-29	2017-11-18
Z-0108-2018	Class II	Ongoing	Voluntary: Firm initiated	2017-11-29	2017-11-18
Z-0109-2018	Class II	Ongoing	Voluntary: Firm initiated	2017-11-29	2017-11-18
Z-0110-2018	Class II	Ongoing	Voluntary: Firm initiated	2017-11-29	2017-11-18
Z-0111-2018	Class II	Ongoing	Voluntary: Firm initiated	2017-11-29	2017-11-18

Product code FPA

K160648Class IIMiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S / cleared 2016-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)