Z-1784-2014Class II

Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use

Name: Z-1784-2014 Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use
Creator: Cordis Corporation
Published: 2013-02-05
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2013-02-05 / Terminated / root cause: manufacturing process

FDA source

Cordis Corporation began a recall of Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use on 2013-02-05. FDA classified it as Class II and gives the reason as "Dilatation catheters could exhibit radial versus axial tears should they burst during inflation". 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-1784-2014
Classification: Class II
Status: Terminated
Initiated: 2013-02-05
Posted: 2014-06-11
Terminated: 2014-06-23
Recalling firm: Cordis US Corp.
Product: Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Product code: LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Reason for recall: Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: An Urgent Medical Device Recall letter and Acknowledgement form was sent overnight to mulitple contacts in each account February 7, 2013. A representative will follow-up as necassary to facility obtaining signature, faxing the acknowledgment form to Cordis, collecting and returning units.
Quantity in commerce: 80 units
Distribution: Worldwide distribution: US states: AZ, FL, IL, LA, MA, NJ, OR, SC, and TX. Armenia, Austria, Belgium, Colombia, Czech Republic, France, Hungary, Iran, Israel, India, Italy, Kuwait, Latvia, Lebanon, Luxembourg, Mexico, Morocco, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Switzerland, and United Arab Emirates.
Product codes and lots: Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1784-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1784-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-11

Product code LOX

K110133Class IIEmpira Rx Ptca Dilatation Catheter, Empria Nc Rx Ptca Dilatation CatheterCreganna-Tactx Medical / cleared 2011-06-10

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)