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 delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731SC catheter. The catheter connects to the pump at the catheter port.
This recall has been terminated (originally issued June 24, 2013).
- Company
- Medtronic Neuromodulation
- Recall Initiated
- June 3, 2013
- Posted
- June 24, 2013
- Terminated
- April 7, 2014
- Recall Number
- Z-1576-2013
- Quantity
- 115,722 total
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The 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.
Distribution
Worldwide 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, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malta, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.
Lot / Code Info
Product having a Use By Date prior to 25 Aug 2014
Root Cause
Device Design
Action Taken
The 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 Confirmation Form will be completed by the Rep. A copy of the completed form will be left with the Hospital along with the Urgent Medical Device Removal letter. If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.