MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91

FDA device recall Z-1691-2013 · posted 2013-07-16 · Terminated

Recall details

Recalling firm

Codman & Shurtleff, Inc.

Reason for recall

Miscalibrated Fill Level Sensor may affect dosing level

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

LKK

Quantity affected

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 Arabi

Date initiated

2013-06-07

Date posted

2013-07-16

Date terminated

2015-04-21

Location

Raynham, MA