FDA Medical Device Recalls (openFDA)
Cordis Corporation: Cordis POWERFLEX PRO PTA Dilatation Catheter 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 post- dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
- Recall number
- Z-0998-2015
- Recalling firm
- Cordis Corporation
- Product
- Cordis POWERFLEX PRO PTA Dilatation Catheter 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 post- dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
- Status
- Terminated
- Initiated
- 2014-12-22
- Posted
- 2015-01-16
- Terminated
- 2015-07-09
- Reason
- One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
- Root cause
- Labeling design
- Action
- The firm, Cordis, sent an "URGENT MEDICAL DEVICE RECALL (Removal)" letter dated December 29, 2014 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately check their inventory to confirm they do not have any units from the demo lot in possession; identify and set aside any unit from the identified lot; review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form; return any affected product to Cordis; share this letter with others in your facility; contact any other facility that has been provided with units of POWERFLEX PRO product; maintain awareness of this notice until all affected product has been returned to Cordis and keep a copy of this notice witn any affected product. For any physician with medical concerns, please contact the Cordis Endovascular Medical Information Line 877-DEVICES Monday through Friday from 9am-5pm. For questions related to the recall that are not adequately addressed in the letter, please contact the Cordis Field Action Coordinator Hal Baden at (786) 313-2365. For questions related to the Acknowledgement Form and its return, please contact Cordis QA at (786) 313-8730.
- Quantity
- 120
- Distribution
- Nationwide Distribution: US including states of: CT, NJ, NY, PA, MD, VA, WV, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, SD, IL, MO, KS, NE, LA, OK, TX, CO, UT, AZ, CA, OR, WA, AR, IN, MN, WY, ND, NV, MA, RI, NH, CT, DE, District of Columbia and Hawaii.
- Lot, serial or model codes
- Catalog 4400615X, demo lot 15617883
- 510(k) numbers
- ["K121442"]
- PMA numbers
- not on file
- Product code
- LIT
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28