Recall Z-0108-2018— Medtronic Inc.

Name: FDA recall Z-0108-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-10

Class II · Ongoing

Class II FDA medical device recall by Medtronic Inc., initiated 2017-09-10. It names one FDA 510(k) clearance: K160648. Product: Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T). Reason: Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin..

Recalling firm: Medtronic Inc.
Classification: Class II
Status: Ongoing
Initiated: 2017-09-10
Firm location: Northridge, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K160648 — MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S·cleared 2016-08-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

Reason for recall

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

Data sourced from openFDA. This site is unofficial and independent of the FDA.