Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Medtronic DxTerity(TM) TRA 5F

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall Medtronic DxTerity(TM) TRA 5Fsee related information
Date Initiated by FirmAugust 16, 2018
Create DateSeptember 26, 2018
Recall Status1 Terminated 3 on May 07, 2021
Recall NumberZ-3253-2018
Recall Event ID 80919
510(K)NumberK161287 
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
ProductMedtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Code Information UDI/GTIN: 20643169738717 Lot Number 60068186
FEI Number 1220452
Recalling Firm/
Manufacturer		 Medtronic Vascular
35-37A Cherry Hill Drive
Danvers MA 01923-2565
For Additional Information ContactJoey Lomicky
763-526-2494
Manufacturer Reason
for Recall		Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.
FDA Determined
Cause 2		Error in labeling
ActionMedtronic initiated consignee communications on 16-Aug-2018 to Risk Managers and Health Care Professionals. US notifications were sent via 2-Day UPS delivery. Consignees are asked to quarantine and return any unused potentially affected product to Medtronic.
Quantity in Commerce250 units
DistributionCA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = DQO
-
-