Z-0910-04

Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT359L6; & MMT-359L9...

Name: Z-0910-04 Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT359L6; & MMT-359L9...
Creator: Medtronic MiniMed
Published: 2004-03-02
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-03-02 / Terminated / root cause: design

FDA source

Medtronic MiniMed began a recall of Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT359L6; & MMT-359L9. (differences in models is variation in length, 6... on 2004-03-02. The reason FDA records is "Possibility of interrupted insulin flow. This posting is for a recall that occurred in March 2004, also posted on the FDA website in 2004". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0910-04
Status: Terminated
Initiated: 2004-03-02
Posted: 2012-03-19
Terminated: 2012-03-19
Recalling firm: Medtronic, Inc.
Product: Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT359L6; & MMT-359L9. (differences in models is variation in length, 6 versus 9mm)
Product code: FPA Set, Administration, Intravascular
Reason for recall: Possibility of interrupted insulin flow. This posting is for a recall that occurred in March 2004, also posted on the FDA website in 2004.
Root cause tag: design
FDA root cause: Component design/selection
Action: Firm will ship all users (customers) one box at a time every three weeks for the next several months. A recall notification letter was issued to users and to healthcare professionals, and distributors. Letters were mailed from March 2-5, 2004.
Quantity in commerce: Undetermined
Distribution: Nationwide
Product codes and lots: All lots

Product code FPA

K030149Class IIMedtronic Minimed Sof-Site Infusion Set, Models Mmt-359S6, Mmt-359M6, Mmt-359L6, Mmt-359S9, Mmt-359M9, and Mmt-359L9Avail Medical Products, Inc. / cleared 2003-03-20

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)