| Class 1 Device Recall Medtronic Intrathecal Catheter | |
Date Initiated by Firm | June 26, 2008 |
Date Posted | September 25, 2008 |
Recall Status1 |
Terminated 3 on June 06, 2011 |
Recall Number | Z-2381-2008 |
Recall Event ID |
48761 |
PMA Number | P860004S081 |
Product Classification |
Intrathecal Catheter - Product Code LKK
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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). |
Code Information |
All SC Catheters |
Recalling Firm/ Manufacturer |
Medtronic Neuromodulation 800 53rd Ave NE PO Box 1250 Minneapolis MN 55440-1250
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For Additional Information Contact | 800-707-0933 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Component design/selection |
Action | 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. |
Quantity in Commerce | 21,674 total |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = LKK
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