ClearanceBrief
Recall Z-1576-2013 ยท LKK Pump, Infusion, Implanted, Programmable

Medtronic Neuromodulation

Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge introducer needle, Transparent Strain-relief sleeves, Opaque Strain-relief sleeves, and V-wing anchors. Contents of inner package are STERILE. The implantable Medtronic Model 8731SC Intrathecal Catheter is part of an infusion system that stores and

DateJun 24, 2013 (initiated Jun 3, 2013)
StatusTerminated
ReasonThe Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.
Root causeDevice Design
ActionThe firm, Medtronic, sent an "Urgent: Medical Device Removal" letter dated May 2013 to its customers. The letter described the product, problem and actions to be taken. Representatives (Rep) are visiting all locations, beginning June 3, 2013, to retrieve devices with a Use By date of 2014 08 14 (August 14, 2014) or sooner. The Rep is leaving a letter with the hospitals to tell them that the Sutureless Connector Intrathecal Catheter connector has been redesigned and that they are removing unused devices. They also do not recommend using any of the old design. An Account Specific Customer C
Quantity115,722 total
DistributionWorldwide distribution: US (nationwide) and countries of: Aruba, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.