• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Cordis Vista Brite Tip AdroitTM Guiding Catheter

  • 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 Cordis Vista Brite Tip AdroitTM Guiding Catheter see related information
Date Initiated by Firm February 07, 2019
Create Date April 18, 2019
Recall Status1 Completed
Recall Number Z-1198-2019
Recall Event ID 82481
510(K)Number K963962  K021593  K992673  K972978  K143412  
Product Classification Catheter, percutaneous - Product Code DQY
Product Cordis Vista Brite Tip & Androit Guiding Catheters

Product Usage:
The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Code Information Lot Number Exp. Date  17744955 12/31/2020  17750783 12/31/2020  17757121 1/31/2021  17735533 10/31/2020  17735534 10/31/2020  17744429 12/31/2020  17744430 12/31/2020  17750785 12/31/2020  17757116 1/31/2021  17748743 12/31/2020  17750476 12/31/2020  17755096 1/31/2021  17757122 1/31/2021  17753002 12/31/2020  17779364 4/30/2021  17815946 9/30/2021  17805148 7/31/2021  17815949 9/30/2021  17753959 1/31/2021  17746022 12/31/2020  17762925 2/28/2021  17733016 10/31/2020  17747583 12/31/2020  17749800 12/31/2020  17752698 12/31/2020  17767925 2/28/2021  17769354 3/31/2021  17771053 3/31/2021  17772929 4/30/2021  17722360 9/30/2020  17735189 10/31/2020  17733019 10/31/2020  17746026 12/31/2020  17747584 12/31/2020  17749793 12/31/2020  17752703 12/31/2020  17754875 1/31/2021  17756762 1/31/2021  17762928 2/28/2021  17771058 3/31/2021  17772931 4/30/2021  17816029 9/30/2021  17817637 9/30/2021  17722359 9/30/2020  17740611 11/30/2020  17778655 4/30/2021  17724480 9/30/2020  17767923 2/28/2021  17771049 3/31/2021  17772926 4/30/2021  17756076 7/31/2020  17816499 3/31/2021  17753948 7/31/2020  17777712 10/31/2020  17816501 3/31/2021  17729208 3/31/2020  17733005 4/30/2020  17736643 4/30/2020  17737608 4/30/2020  17740605 5/31/2020  17742559 5/30/2020  17743099 6/30/2020  17743101 6/30/2020  17745965 6/30/2020  17756074 7/31/2020  17816500 3/31/2021  17756075 7/31/2020  17746147 12/31/2020  17807995 8/31/2021  17811028 8/31/2021  17814511 9/30/2021  17818155 9/30/2021  17755015 1/31/2021  17724819 9/30/2020  17742581 11/30/2020  17756975 1/31/2021  17771328 3/31/2021  17794750 6/30/2021  17814264 9/30/2021  17816167 9/30/2021  17750494 12/31/2020  17817649 9/30/2021  17800760 7/31/2021  17801566 7/31/2021  17802170 7/31/2021  17802171 7/31/2021  17803141 7/31/2021  17803142 7/31/2021  17803143 7/31/2021  17803536 7/31/2021  17803539 7/31/2021  17803540 7/31/2021  17804225 7/31/2021  17804226 7/31/2021  17804764 7/31/2021  17805447 7/31/2021  17805899 8/31/2021  17805901 8/31/2021  17806219 8/31/2021  17806330 8/31/2021  17806331 8/31/2021  17806332 8/31/2021  17806706 8/31/2021  17807595 8/31/2021  17807603 8/31/2021  17807626 8/31/2021  17807628 8/31/2021  17807629 8/31/2021  17809536 8/31/2021  17809537 8/31/2021  17809538 8/31/2021  17809786 8/31/2021  17809791 8/31/2021  17809792 8/31/2021  17809793 8/31/2021  17810429 8/31/2021  17810430 8/31/2021  17810432 8/31/2021  17810433 8/31/2021  17811219 8/31/2021  17811220 8/31/2021  17811221 8/31/2021  17811677 8/31/2021  17811834 8/31/2021  17811836 8/31/2021  17811837 8/31/2021  17811839 8/31/2021  17812321 8/31/2021  17813158 9/30/2021  17813159 9/30/2021  17814278 9/30/2021  17814279 9/30/2021  17814640 9/30/2021  17814641 9/30/2021  17814642 9/30/2021  17814643 9/30/2021  17815025 9/30/2021  17815340 9/30/2021  17817001 9/30/2021  17817002 9/30/2021  17817004 9/30/2021  17817285 9/30/2021  17818563 9/30/2021  17818564 9/30/2021  17819221 9/30/2021  17819222 9/30/2021  17821534 10/31/2021  17800613 7/31/2021  17800614 7/31/2021  17800615 7/31/2021  17802172 7/31/2021  17803537 7/31/2021  17803538 7/31/2021  17804026 7/31/2021  17804222 7/31/2021  17804223 7/31/2021  17804224 7/31/2021  17804765 7/31/2021  17804766 7/31/2021  17805898 7/31/2021  17805900 8/31/2021  17805902 8/31/2021  17806214 8/31/2021  17807627 8/31/2021  17808004 8/31/2021  17809486 8/31/2021  17811835 8/31/2021  17815021 9/30/2021  17815022 9/30/2021  17815023 9/30/2021  17815024 9/30/2021  17817003 9/30/2021  17819220 9/30/2021  
Recalling Firm/
Manufacturer
Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014-2802
For Additional Information Contact
786-313-2000
Manufacturer Reason
for Recall
Frayed pieces of the mounting card being inside the primary packaging.
FDA Determined
Cause 2
Equipment maintenance
Action A letter and Acknowledgement Form will be sent overnight on February 07, 2019 to the direct consignees. The letter provides instructions to our direct consignees to notify any additional consignees or departments as to the market action. For health care professionals with medical concerns, please contact the Cordis Endovascular Medical Information Line 877-DEVICE5 (877-338-4235, Monday through Friday from 9:00 AM to 5:00 PM EST. For questions related to the recall and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 1(800)292-9332
Quantity in Commerce 23481
Distribution Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and Guam Singapore and Canada
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.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = CORDIS CORP.
510(K)s with Product Code = DQY and Original Applicant = CORDIS CORPORATION
-
-