Recall Z-0998-2015— Cordis Corporation

Name: FDA recall Z-0998-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-22

Class II · Terminated

Class II FDA medical device recall by Cordis Corporation, initiated 2014-12-22, terminated 2015-07-09. It names one FDA 510(k) clearance: K121442. 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.. Reason: One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized..

Recalling firm: Cordis Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-12-22
Terminated: 2015-07-09
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K121442 — POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERCordis Corporation·cleared 2012-06-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.

Data sourced from openFDA. This site is unofficial and independent of the FDA.