Class 2 Device Recall POWERFLEX PRO Percutaneous Transluminal Angioplasty (PTA) Catheter

• Date Initiated by Firm: September 05, 2018
• Create Date: November 06, 2018
• Recall Status: Terminated on February 11, 2021
• Recall Number: Z-0390-2019
• Recall Event ID: 81294
• 510(K)Number: K121442
• Product Classification: Catheter, angioplasty, peripheral, transluminal - Product Code LIT
• Product: Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
• Code Information: Catalog Number Lot Number Expiry Date 4400322X 82144115 2020-04-30; 4400602S 82144141 2020-05-31; 4400515X 82144947 2020-06-30; 4400308S 82148810 2020-11-30; and 4400508S 82148811 2020-11-30.
• FEI Number: 1016427
• Recalling Firm/ Manufacturer: Cordis Corporation; 14201 NW 60th Ave; Miami Lakes FL 33014-2802
• For Additional Information Contact: Cordis Endovascular Medical Information Line; 800-292-9332
• Manufacturer Reason for Recall: Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
• FDA Determined Cause: Process control
• Action: A letter dated September 5, 2018 was sent to all their customers by Cordis with the following request: 1) Read this Urgent Medical Device Recall letter. 2) Immediately check your inventory to confirm that you do not have any units from the affected lots in your possession. Identify and set aside any units from the identified lots in a manner that ensures the affected product will not be used. Check all storage and usage locations. 3) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. 4) Return any affected product to the address listed on the form, with reference to your Customer Number which is listed on the form. 5) Share this letter with others in your facility who need to be made aware of this recall. 6) Please contact any other facility that may have been sent the affected units of POWERFLEX PRO product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. 7) Maintain awareness of this notice until all affected product has been returned to Cordis 8) Keep a copy of this notice with the affected product. For any health care professional 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 that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com For questions related to the Acknowledgement Form and its return, please call (800)292-9332.
• Quantity in Commerce: 162 units total (74 units in USA)
• Distribution: Worldwide distribution - US Nationwide in the states of AL, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MO, MS, NC, ND, NJ, OH, PA, SC, TN, TX, and WI. Countries of Japan and Netherlands.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = LIT