Z-0390-2019Class II

Cordis POWERFLEX PRO PTA Dilatation Catheter -

Name: Z-0390-2019 Cordis POWERFLEX PRO PTA Dilatation Catheter -
Creator: Cordis Corporation
Published: 2018-09-05
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2018-09-05 / Terminated / root cause: manufacturing process

FDA source

Cordis Corporation began a recall of Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and... on 2018-09-05. FDA classified it as Class II and gives the reason as "Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0390-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-05
Posted: 2018-11-06
Terminated: 2021-02-11
Recalling firm: Cordis US Corp.
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.
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
Root cause tag: manufacturing process
FDA root 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: [email protected] 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0390-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0390-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)