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.
This recall has been terminated (originally issued September 5, 2018).
- Company
- Cordis Corporation
- Recall Initiated
- September 5, 2018
- Terminated
- February 11, 2021
- Recall Number
- Z-0390-2019
- Quantity
- 162 units total (74 units in USA)
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
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.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
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.