Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
FDA Recall Z-0108-2018 · Posted None
Recalling FirmMedtronic Inc.
Recall StatusOpen, Classified
Product CodeFPA
Date Initiated2017-09-10
Product Quantity1,898,570 units
Reason for Recall
Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Worldwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.