—#68305

Product

Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model Number: 8596SC; Packaged with catheter model number 8731 or 8731SC.

FDA product code: LKK — Pump, Infusion, Implanted, Programmable
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P860004S081
Affected lot / code info: Lot Numbers: N131154001, N131154003, N131154004, N131154008, N131154009, N131154010, N131154013, N131154016, N131154017, N130483001, N130483004, N130483006, N130483011, N130483012, N130483013, N130483014, N130483015 and N130483021.

Why it was recalled

Incorrect Connector Pin: The Medtronic 8596SC Intrathecal Catheter Pump Segment Revision kits were packaged with the incorrect connector pin.

Root cause (FDA determination)

Packaging process control

Action the firm took

Consignees were notified by an Urgent Medical Device Recall letter sent in January 2008. The letter informed users that the recalling firm would contact them regarding removing the affected products from their inventory. Users were requested to return a response form indicating the number of affected product. For additional information, contact 1-800-707-0933.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 800 53rd Ave NE PO Box 1250, Minneapolis, Minnesota 55440-1250

Distribution

Distribution pattern: Nationwide Distribution including states of MI, OR, IN, NY, FL, PA, MN, TX, CO and UT.

Timeline

Recall initiated: 2008-01-09
Posted by FDA: 2008-07-22
Terminated: 2010-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68305. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.