Recalls / —

—#176860

Product

Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.

FDA product code

LIT — Catheter, Angioplasty, Peripheral, Transluminal

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K991811

Affected lot / code info

Catalog Number: 4171460S; Lot Number: 82169860; Expiry Date: 10/31/2020

Why it was recalled

Product was manufactured utilizing an expired inner body.

Root cause (FDA determination)

Process control

Action the firm took

Cordis notified customers on about 10/04/2019, via Urgent MEDICAL DEVICE RECALL letter delivered by sales representatives. Customers were informed that the Cordis MAXI LD" PTA Dilatation Catheter was manufactured utilizing an expired inner body. For an expired inner body, a degradation of material may contribute to a collapse of the guidewire lumen resulting in a resistance during insertion or backloading of the guidewire into the lumen. Instructions included to read the recall letter, immediately check inventory to conform if the affected product is in your possession, identify and set aside any units from the affected lot, complete and return the provided Acknowledgement Form directly to Cordis via fax (614-495-5571) or email to GMB-FieldCorrectiveAction@cardinalhealth.com. Customers were also instructed to arrange for return of affected product, provide the recall letter to personnel at your facility who need to be made aware and any other facility that may have been sent the affected units.

Recalling firm

Firm

Cordis Corporation

Address

14201 NW 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern

US distribution to AL, AZ, FL, MN, and MO

Timeline

Recall initiated

2019-10-04

Terminated

2020-12-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #176860. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.