Class 1 Device Recall MedStream Programmable Infusion Pump

• Date Initiated by Firm: June 07, 2013
• Date Posted: July 16, 2013
• Recall Status: Terminated on April 21, 2015
• Recall Number: Z-1690-2013
• Recall Event ID: 65420
• PMA Number: P890055
• Product Classification: Pump, infusion, implanted, programmable - Product Code LKK
• Product: MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.
• Code Information: All serial numbers
• Recalling Firm/ Manufacturer: Codman & Shurtleff, Inc.; 325 Paramount Drive; Raynham MA 02767
• For Additional Information Contact: 508-880-8100
• Manufacturer Reason for Recall: Miscalibrated Fill Level Sensor may affect dosing level
• FDA Determined Cause: Device Design
• Action: Codman issued a Medical Device Correction Notification to Medical Facilities dated June 7, 2013 via FedX to inform them of the potential problem and a Worksheet (instructions) to Identify Pumps with Miscalibrated FLS during each patient's next scheduled refill session or sooner if patient is symptomatic. If a pump is identified as having a miscalibrated FLS, notify Codman Neuro using the same worksheet. In addition a sample letter was provided to Physi cans to provide to patients on the system. Follow the recommendations for managing patients who are identified as having a pump with a miscalibrated FLS. For additional information,contact your Codman Neuro representative, or contact Codman Neuro Clinical Support at 1-800-660-2660. Please report any malfunction or adverse event related to this device to Codman Neuro at 1-866-491-0974, Option 2.
• Quantity in Commerce: 2 units US and 735 OUS
• Distribution: Worldwide Distribution-USA (nationwide) including the states of FL, NC, NJ, and TX, and the countries of Austria, Belgium, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, Portugal, Greece, Egypt, Switzerland, and Turkey.
• Total Product Life Cycle: TPLC 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 Database: PMAs with Product Code = LKK