MedStream Programmable Infusion Pump

Recall Class: Class I

Date Recall Initiated: June 7, 2013

Products: MedStream Programmable Infusion Pump

Models: 91-4200US 20 ml pump, .91-4201US 40 ml pump, 91-4200 20 ml pump, 91-4201 40 ml pump

These affected products were distributed from July, 2009 through June, 2013.

Use: The MedStream Programmable pump is an implanted device intended for the intrathecal delivery of the drug Baclofen.

Recalling Firm:
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham, MA 02767
FEI 3002947440

Medos International SARL

Chemin-Blanc 38
CH 2400 Le Locle, Switzerland
FEI 3008114965

Reason for Recall: The Fill Level Sensor (FLS), a component of the Medstream Programmable Infusion Pump, may malfunction. The Fill Level Sensor is intended to measure the contents of the pump drug reservoir. The malfunction in the Fill Level Sensor may cause the pump’s low reservoir alarm, normally set at 3 ml, to sound too early or too late. The recommended pump refill date, computed by the Control Unit, may be incorrect. A late sounding alarm could result in a pump not being refilled in time, which could result in the under delivery or discontinuation of medications like Baclofen. This could result in serious medical illness or death.

Public Contact: For questions about this action 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.

FDA District: New England District Office