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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic Sutureless Pump Connector Revision Kit

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 Class 1 Device Recall Medtronic Sutureless Pump Connector Revision Kitsee related information
Date Initiated by FirmJune 26, 2008
Date PostedSeptember 25, 2008
Recall Status1 Terminated 3 on June 06, 2011
Recall NumberZ-2382-2008
Recall Event ID 48761
PMA NumberP860004S081 
Product Classification Intrathecal Catheter - Product Code LKK
ProductMedtronic 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).
Code Information All SC Catheter Revision Kits
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
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
ActionMedtronic 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 Commerce21,674 total
DistributionWorldwide 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 CycleTPLC Device Report
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.
PMA DatabasePMAs with Product Code = LKK
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