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FDA Medical Device Recalls (openFDA)

Medtronic MiniMed: 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)

Recall number
Z-0910-04
Recalling firm
Medtronic MiniMed
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)
Status
Terminated
Initiated
2004-03-02
Posted
2012-03-19
Terminated
2012-03-19
Reason
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
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
Undetermined
Distribution
Nationwide
Lot, serial or model codes
All lots
510(k) numbers
["K030149"]
PMA numbers
not on file
Product code
FPA
Firm FEI
3003166194
Firm city
Northridge
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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