Recall Z-2383-2008 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 66-cm pump segment with attached sutureless pump connector, spinal segment strain-relief sleeves (2), Pump segment strain-relief sleeves (2), Connector pin.
| Date | Sep 25, 2008 (initiated Jun 26, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 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, Nether |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.