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U.S. Department of Health and Human Services

Class 1 Device Recall MedStream Programmable Infusion Pump

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  Class 1 Device Recall MedStream Programmable Infusion Pump see related information
Date Initiated by Firm June 07, 2013
Date Posted July 16, 2013
Recall Status1 Terminated 3 on April 21, 2015
Recall Number Z-1691-2013
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:
91-4201US (40ml pump)
91-4201 (40ml pump)

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 2		 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 5 US and and 360 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 and Original Applicant = Intera Oncology
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