Skip to content

MedStream Programmable Infusion Pump , Implantable for the… recallZ-1691-2013 · Codman & Shurtleff, Inc. · initiated Jun 7, 2013

Class I Terminated All recalls posted in July 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Codman & Shurtleff, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Miscalibrated Fill Level Sensor may affect dosing level

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1691-2013
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Jun 7, 2013
Posted by the FDA
Jul 16, 2013
Recalling firm
Codman & Shurtleff, Inc.
Quantity
5 US and and 360 OUS
Product code
LKK
FDA submissions
P890055
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.

Product description

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 (models, lots, serial numbers)

All serial numbers

Other devices under the same FDA submission

6 devices cleared under P890055 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 65420).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page