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.
This recall has been terminated (originally issued June 14, 2007).
- Company
- St Jude Medical Crmd
- Recall Initiated
- March 20, 2007
- Posted
- June 14, 2007
- Terminated
- February 29, 2012
- Recall Number
- Z-0933-2007
- Quantity
- 14,000
- Firm Location
- Sylmar, CA
- Official Source
- View on FDA website ↗
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.
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, Hong Kong, Korea, Malaysia and Singapore.
Lot / Code Info
Models: CPS Direct SL (Models 410110; 410111; 410112; 410113; 410114; 410115; 410116; 410120; 410121; 410122; 410123; 410124; 410126). CODE INFORMATION: All devices with sterile lot numbers beginning with S, CR, or any C4 lot numbers starting with CP 05274 or higher.
Root Cause
Other
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.