FDA Medical Device Recalls (openFDA)
Cordis Corporation: Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
- Recall number
- Z-1784-2014
- Recalling firm
- Cordis Corporation
- Product
- Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
- Status
- Terminated
- Initiated
- 2013-02-05
- Posted
- 2014-06-11
- Terminated
- 2014-06-23
- Reason
- Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
- 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
- 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.
- Lot, serial or model codes
- Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08
- 510(k) numbers
- ["K110133"]
- PMA numbers
- not on file
- Product code
- LOX
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28