Z-0250-2020Class II

Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use

Name: Z-0250-2020 Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use
Creator: Cordis Corporation
Published: 2019-10-04
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2019-10-04 / Terminated / root cause: manufacturing process

FDA source

Cordis Corporation began a recall of Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use on 2019-10-04. FDA classified it as Class II and gives the reason as "Product was manufactured utilizing an expired inner body". 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-0250-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-04
Posted: 2019-10-30
Terminated: 2020-12-14
Recalling firm: Cordis US Corp.
Product: Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: Product was manufactured utilizing an expired inner body.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected]. 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.
Quantity in commerce: 21 units
Distribution: US distribution to AL, AZ, FL, MN, and MO
Product codes and lots: Catalog Number: 4171460S; Lot Number: 82169860; Expiry Date: 10/31/2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0250-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0250-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-30

Product code LIT

K991811Class IICordis Maxi Ds Pta Balloon CatheterCordis Corp. / cleared 1999-06-15

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)