Recall Z-1477-2020— Cordis Corporation

Name: FDA recall Z-1477-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-08

Class II · Terminated

Class II FDA medical device recall by Cordis Corporation, initiated 2020-01-08, terminated 2023-01-13. It names one FDA 510(k) clearance: K032737. Product: Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S. Reason: Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area..

Recalling firm: Cordis Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-01-08
Terminated: 2023-01-13
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K032737 — CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTACordis Europa, N.V.·cleared 2003-10-02

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 P3, PTA Dilation Catheter, REF 420-6020S

Reason for recall

Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.

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