Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: Catheter interface with attached sutureless pump

FDA device recall Z-2382-2008 · posted 2008-09-25 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

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.

Action taken

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

Status

Terminated

Product code

LKK

Quantity affected

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,

Date initiated

2008-06-26

Date posted

2008-09-25

Date terminated

2011-06-06

Location

Minneapolis, MN