Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
FDA device recall Z-1784-2014 · posted 2014-06-11 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LOX
- Quantity affected
- 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, Lu
- Date initiated
- 2013-02-05
- Date posted
- 2014-06-11
- Date terminated
- 2014-06-23
- Location
- Miami Lakes, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER (K110133) | Creganna-Tactx Medical | 2011-06-10 |