—#72071

Product

Medtronic Intrathecal Catheter, model 8731SC. 38.1 cm spinal segment with length markers and guide wire, 66 cm pump segment, separate connector pin, 15T gauge introducer needles (2) (11.4 cm and 9.3 cm), Transparent strain-relief sleeves (2), Opaque Strain-relief sleeves (2), V-wing Anchors (2).

FDA product code: LKK — Pump, Infusion, Implanted, Programmable
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P860004S081
Affected lot / code info: All SC Catheters

Why it was recalled

Disconnection of the Medtronic sutureless connector (SC) catheters from the catheter port on the pump, or occlusion between the sutureless pump connector and the catheter port on the pump.

Root cause (FDA determination)

Component design/selection

Action the firm took

Medtronic sent A Safety Alert dated June 2008, on June 27, 2008, to healthcare professionals, which described the issues of occlusion and disconnect. The letter identifies the affected catheter and revision kit model numbers and the associated implantable infusion pumps. The issues do not involve Medtronic MiniMed insulin pump. The letter refers the HCP to recommendations for Implant Techniques and Recommendations for Patency Verification that are included with the letter. The letter also includes recommendations for managing patients with implanted SC catheters.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution: USA, Puerto Rico, Algeria, Aruba, Austria, Australia, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

Timeline

Recall initiated: 2008-06-26
Posted by FDA: 2008-09-25
Terminated: 2011-06-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72071. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.