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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
St Jude Medical CRMD
Lot Codes / Batch Numbers
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.
Products Sold
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.
St Jude Medical CRMD is recalling St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410 due to Device Separation- product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, GA, IN, KS, LA, ME, MD, MA, MI, MN, MS, NH, NY, NC, OH, PA, RI, TN, VA, WI, DC
Page updated: Jan 10, 2026