Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC, Method of Sterilization: Ethylene Oxide. Medtron

FDA device recall Z-2075-2009 · posted 2009-09-10 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Current labeling for Medtronic Sutureless Connector (SC) catheters and revision kits (hereafter referred to as SC catheters) incorrectly states that SC catheters are compatible with Medtronic IsoMed constant-flow infusion pumps. SC catheters are compatible with Medtronic SynchroMed II and SynchroMed EL pumps. Medtronic has determined that SC catheters are not compatible with IsoMed pumps.

Action taken

A "Medical Device Correction Notification" letter was issued on August 14, 2009 to implanting and managing physicians. The letter described the nature of the issue, scope of affected product, potential severity of the issue and provided recommendations. Physicians were instructed that Sutureless Connector (SC) catheters must not be used with IsoMed pumps for future revisions and implants. A copy of the letter was also sent to the Risk Manager at each hospital associated with physicians using SC catheters. Healthcare professionals were asked to complete and return the enclosed reply card. Direct questions to your Medtronic field representative or contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. Patient Management information is also available at http://www.professional.medtronic.com under the Heading, "Advisories".

Root cause

Device Design

Status

Terminated

Product code

LKK

Quantity affected

20,000 of all products

Distribution

Worldwide Distribution -- US (including Washington D.C. and Puerto Rico), Algeria, Aruba, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finl

Date initiated

2009-08-27

Date posted

2009-09-10

Date terminated

2011-12-12

Location

Minneapolis, MN