Z-0998-2015Class II

Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral...

Name: Z-0998-2015 Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral...
Creator: Cordis Corporation
Published: 2014-12-22
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2014-12-22 / Terminated / root cause: labeling and UDI

FDA source

Cordis Corporation began a recall of Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for... on 2014-12-22. FDA classified it as Class II and gives the reason as "One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0998-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-22
Posted: 2015-01-16
Terminated: 2015-07-09
Recalling firm: Cordis US Corp.
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.
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Catalog 4400615X, demo lot 15617883

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0998-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0998-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-28	2015-01-16

Product code LIT

K121442Class IIPowerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation / cleared 2012-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)