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.
FDA Recall Z-0390-2019 · Posted None
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Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeLIT
Date Initiated2018-09-05
Date Terminated2021-02-11
Product Quantity162 units total (74 units in USA)
Reason for Recall
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
Firm 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:
[email protected]
For questions related to the Acknowledgement Form and its return, please call (800)292-9332.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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