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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic MiniMed(TM) SureT(TM)

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  Class 2 Device Recall Medtronic MiniMed(TM) SureT(TM) see related information
Date Initiated by Firm September 10, 2017
Create Date November 18, 2017
Recall Status1 Open3, Classified
Recall Number Z-0109-2018
Recall Event ID 78125
510(K)Number K160648  
Product Classification Set, administration, intravascular - Product Code FPA
Product Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
Code Information Lot Numbers: 5188321 5190185 5190186 5184968 5185467 5185468 5185469 5185470 5188322 5188323 5188324 5188325 5188326 5188327 5188328 5189476 5189477 5189478 5189521 5189522 5190187 5190188 5190189 5191046 5191047 5191355 5192532 5183060 5183061 5187300 5187301 5187556 5187557 5189051 5193052 5188329 5188330 5189053 5189054 5194937 5185690 5187558 5191357 5187559 
Recalling Firm/
Manufacturer		 Medtronic Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Medtronic
888-204-7616
Manufacturer Reason
for Recall		 Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
FDA Determined
Cause 2		 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 2,163,610 units
Distribution Worldwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = UNOMEDICAL A/S
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