Recall Class: Class I
Date Recall Initiated: June 3, 2013
- Sutureless Connector Intrathecal Catheters, Models 8709SC, 8731SC
- Sutureless Revision Kits, Models 8596SC, 8578
This recall affects Sutureless Connector Intrathecal Catheter products with a Use by Date of August 14, 2014 or sooner.
The affected products were manufactured from November 21, 2006 to August 24, 2012 and distributed from January 23, 2007 to March 27, 2013.
Use: The Sutureless Connector Intrathecal Catheter and Revision Kits are accessories to an implanted infusion system designed to store and deliver parenteral drugs to the Intrathecal space. The implanted infusion system components consist of a Medtronic SynchroMed implantable drug infusion pump and an Intrathecal Catheter. The Sutureless Revision Kit is used when a pump connector for an Intrathecal Catheter is required.
Medtronic, Inc., Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568
Medtronic Puerto Rico Operations Co.
50 Road 31 km 24.4 Ceiba Norte Ind Park
Juncos, Puerto Rico 00777
Reason for Recall: The Sutureless Connector Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion, which is the blockage or stoppage of drug flow due to misalignment at the point where the catheter connects to an implantable pump. Medtronic is removing all unused products that were manufactured with the previous design. Medtronic recommends the previous design of Sutureless Connector Intrathecal Catheter Products no longer be used due to greater potential for misalignment and subsequent occlusion.
This product may cause serious adverse health consequences, including drug under dose, loss of symptom relief, drug withdrawal symptoms caused by the lack of drug delivery to the Intrathecal space, and/or death.
Public Contact: For questions about this recall, contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 Monday through Friday, 7 AM through 6 PM Central Standard Time.
FDA District: Minneapolis District Office
FDA Comments: On June 3, 2013, Medtronic sent an "Urgent: Medical Device Removal" letter dated May 2013 to all affected customers. The letter described the product, problem, and actions to be taken.
On June 13, 2013, Medtronic Representatives began visiting all locations to retrieve devices with a Use by Date of August 14, 2014 or sooner. Representatives are 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.
Medtronic does not recommend the use of any affected devices with the old design.
An Account Specific Customer Confirmation Form will be completed by the representative. A copy of the completed form will be left with the Hospital along with the "Urgent: Medical Device Removal" letter.
Customers with questions related to the removal of affected products, please contact your Medtronic representative or Customer Service at 1-888-638-7627.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.