Z-0111-2018Class II

Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)

Name: Z-0111-2018 Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
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) Pro-set(TM) (MMT-280, 281) 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-0111-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-09-10
Posted: 2017-11-18
Recalling firm: Medtronic, Inc.
Product: Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
Product code: FPK Tubing, Fluid Delivery
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: 5,842 units
Distribution: Worldwide
Product codes and lots: Lot Numbers: 6211649, 6207537

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0111-2018
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 FPK

K160651Class IIBD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company / cleared 2016-04-07

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)