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 2 Device Recall Cordis S.M.A.R.T. Flex Vascular Stent System

  • 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 2 Device Recall Cordis S.M.A.R.T. Flex Vascular Stent Systemsee related information
Date Initiated by FirmFebruary 16, 2017
Create DateApril 15, 2017
Recall Status1 Terminated 3 on August 06, 2019
Recall NumberZ-1826-2017
Recall Event ID 76800
Product Classification Stent, coronary - Product Code MAF
ProductCordis S.M.A.R.T. Flex Vascular Stent System
Code Information 1.) Catalog Numbers SF05200MV, Size 5 x 200mm, Catheter length 120 cm GTIN -Carton Level 20705032066829 Lot #'s: 34551, 34552, 34585, 34586, 34587, 35009, 35199, 35228, 35706, 35741, 35859, 35860, 36160, 36275, 36380, 36666, 36792, 36859, 36902, 36903, 37007, 37091, 37155, 37349, 37350, 37350, 37961, 37962, 38059, 38315, 38515, 38529, 38529, 38628, 38629, 39001, 39002, 39195, 39398, 39427, 39644, 39862, and 39974 2.) Catalog Numbers SF05200SV, Size 5 x 200mm, Catheter length 80 cm GTIN -Carton Level 20705032066409 Lots #'s: 35707, 35742, 35965, 36161, 36667, 36793, 37351, 37963, 39158, 39351, 39352, 39554, 39641, and 39863 3.) Catalog Numbers SF06200MV, Size 6 x 200mm, Catheter length 120 cm GTIN -Carton Level 20705032066836 Lots #'s: 34469, 34470, 34588, 34589, 34823, 3487534993, 35006, 35068, 35069, 35229, 35287, 35352, 35469, 35470, 35715, 35755, 35823, 35868, 35945, 35971, 36032, 36033, 36163, 36279, 36322, 36388, 36537, 36678, 36742, 36804, 36865, 37019, 37106, 37168, 37250, 37352, 37707, 37975, 38063, 38282, 38319, 38429, 38513, 38569, 38747, 38850, 38921, 39007, 39162, 39200, 39267, 39358, 39405, 39949, and 39955 and  4.) Catalog Numbers SF06200SV Size 5 x 200mm, Catheter length 80 cm GTIN -Carton Level 20705032067024 Lots #'s 35077, 35165, 35361, 35500, 35568, 35597, 35716, 35756, 35824, 35946, 35972, 36034, 36164, 36538, 36679, 36680, 36805, 37107, 37169, 37541, 37579, 37708, 38064, 38167, 38168, 38320, 38321, 38530, 38748, 39201, 39439, 39440, 39645, 39646, 39959, and 39971   ALL UNEXPIRED LOTS NUMBERS 
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		Deployment Difficulty.
FDA Determined
Cause 2		Other
ActionEmail to the Cardinal Health and J&J country entities sent February 16, 2017. Each country will perform the recall locally. (This is an OUS only Removal.)
Quantity in Commerce2,700
DistributionFOREIGN ONLY: ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, IRAN, ISRAEL, ITALY, JORDAN, KOREA (South), KUWAIT, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, POLAND, PORTUGAL, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, and UNITED KINGDOM
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.
-
-