Recall Z-0390-2019— Cordis Corporation

Name: FDA recall Z-0390-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-05

Class II · Terminated

Class II FDA medical device recall by Cordis Corporation, initiated 2018-09-05, terminated 2021-02-11. It names one FDA 510(k) clearance: K121442. 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.. Reason: Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test)..

Recalling firm: Cordis Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-09-05
Terminated: 2021-02-11
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 - 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.

Reason for recall

Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).

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