Recall Z-0933-2007 ยท MCX Catheter, Coronary, Atherectomy
St Jude Medical CRMD
St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126.
| Date | Jun 14, 2007 (initiated Mar 20, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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, France, Germany, Italy, UK, Spain, Portugal, Poland, Switzerland, Australia, New Zealand, Thailand, Hon |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053277 | CPS DIRECT SL OUTER CATHETER St Jude Medical, Feb 24, 2006 |