Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: Catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve, Strain-relief Sleeves (2).
FDA Recall Z-2382-2008 · Posted 2008-09-25
Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeLKK
Date Initiated2008-06-26
Date Terminated2011-06-06
Product Quantity21,674 total
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.
Firm 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.
Root Cause
Component design/selection
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.