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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis Precise Nitinol Stent System

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  Class 2 Device Recall Cordis Precise Nitinol Stent System see related information
Date Initiated by Firm November 14, 2019
Create Date December 20, 2019
Recall Status1 Open3, Classified
Recall Number Z-0729-2020
Recall Event ID 84228
PMA Number P030047 
Product Classification Stent, carotid - Product Code NIM
Product Cordis Precise Nitinol Stent System.
The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. The stent is cut from a solid nitinol tube into a fine mesh ( Z configuration) design. The delivery systems consist mainly of an inner shaft and an outer sheath with radiopaque markers, and a Tuohy Borst valve. The inner shaft terminates distally in a catheter tip and originates proximally in a luer hub designed to accept a 0.018 guidewire. The delivery systems have a nominal working length of 135 cm. The self-expanding PRECISE stent is constrained within the space between the inner shaft and the outer sheath, located between distal and proximal stent makers on the inner shaft. The stent expands to its unconstrained diameter when released from the deployment catheter into the carotid artery. Upon deployment the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery.
Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2mm smaller in diameter than the unconstrained diameter of the stent.
Code Information All Lot Codes. Affected SKUs: N1020SB, N1020SB, N1020SC, N1030SB, N1030SB, N1030SC, N1040SB, N1040SB, N1040SC, N520SB, N520SC,  N530SB, N530SC, N540SB, N540SC, N620SB, N620SC, N630SB, N630SC, N640SB, N640SC, N720SB, N720SC, N730SB, N730SC, N740SB, N740SC,  N820SB, N820SB, N820SC, N830SB, N830SB, N830SC, N840SB, N840SB, N840SC, N920SB, N920SB, N920SC, N930SB, N930SB, N930SC, N940SB, N940SB, N940SC, P05020RXB, P05030RXB, P05040RXB, P0520RXCE, P0530RXCE, P0540RXCE, P06020RXB, P06030RXB, P06040RXB, P0620RXCE, P0630RXCE, P0640RXCE, P07020RXB, P07030RXB, P07040RXB, P0720RXCE, P0730RXCE, P0740RXCE, P08020RXB, P08030RXB, P08040RXB, P0820RXCE, P0830RXCE, P0840RXCE, P09020RXB, P09030RXB, P0920RXCE, P0930RXCE, P0940RXCE, P10020RXB, P1020RXCE, P1030RXCE, P1040RXCE.               
Recalling Firm/
Manufacturer		 Cardinal Health Inc.
7000 Cardinal Pl
Dublin OH 43017-1091
For Additional Information Contact Cordis Endovascular Medical Info Line
877-338-4235
Manufacturer Reason
for Recall		 Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers were notified with a Medical Device Correction letter. The letter was sent via overnight delivery beginning 11/14/2019. The letter identified affected product, provided a description of the problem, and asked that a copy of the letter be retained where the product is stored. Customer were asked to completed and return an Acknowledgement Form. Questions can be directed to the Cordis Endovascular Medical Information Line 877-DEVICE5 (877-338-4235) Monday through Friday 9:00 am - 5:00 pm EST.
Quantity in Commerce 267,247 units total (262,641 OUS, 4,606 US)
Distribution Worldwide distribution - US Nationwide including Puerto Rico and countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaiian, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Repulic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Maldives, Malta, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saint-Barthelemy, Saudia Arabia, Sinapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela.
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.
PMA Database PMAs with Product Code = NIM and Original Applicant = Cordis US Corporation
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