Z-1784-2014 Class II Terminated
FDA device recall Z-1784-2014 was initiated by Cordis Corporation on Feb 5, 2013 and is designated Class II. Reason for recall: Dilatation catheters could exhibit radial versus axial tears should they burst during inflation. The recall status is terminated (terminated Jun 23, 2014). Affected quantity: 80 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 18, 2014
- Initiation Date
- Feb 5, 2013
- Termination Date
- Jun 23, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 units
Product Description
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Reason for Recall
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
Distribution Pattern
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.
Code Information
Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1784-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026