St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114,
FDA device recall Z-0933-2007 · posted 2007-06-14 · Terminated
Recall details
- Recalling firm
- St Jude Medical CRMD
- Reason for recall
- Device Separation- product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure.
- Action taken
- By Letter dated March 20, 2007, customers were requested to returned affected product immediately to St. Jude Medical. St. Judes Sales Representative will be assisting customers in retrieving the subject inventory from their shelves. The firm instructed customers that if they should require further information regarding this issue, to contact the firm's Technical Service department at (800) 722-3774 or customers can contact local St. Jude Medical representative.
- Root cause
- Other
- Status
- Terminated
- Product code
- MCX
- Quantity affected
- 14,000
- Distribution
- Worldwide-including states of AZ, CA DC, FL GA, IN, KS, LA, MA, MD, ME, MI, MN, MS, NC, NH, NY, OH, PA, RI, TN, VA, and WI and countries of Austria, Belgium, Denmark, Finland, Netherlands, Sweden, Fra
- Date initiated
- 2007-03-20
- Date posted
- 2007-06-14
- Date terminated
- 2012-02-29
- Location
- Sylmar, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CPS DIRECT SL OUTER CATHETER (K053277) | St Jude Medical | 2006-02-24 |