Recall Class: Class I
Date Recall Initiated: August 13, 2013
|MedStream Programmable Pump; 20 mL||US: 91 – 4200
EMEA: 91 – 4200
|MedStream Programmable Pump; 40 mL||US: 91 – 4201
EMEA: 91 – 4201
|MedStream Refill Kit||US: 91 – 4287
EMEA: 91 – 4289
|MedStream Refill Kit; 6 Pack||US: 91 – 4288
EMEA: 91 – 4290
The affected products were manufactured from March 2009 to September 2012 and distributed from January 08, 2010 to July 19, 2013.
Use: The MedStream Programmable Infusion Pump is an implanted drug delivery system used in the US for the chronic delivery of Baclofen to treat muscle symptoms and used in Europe, Middle East, and Africa (EMEA) for the chronic delivery of Morphine or Baclofen. Refill kits are used in filling and re-filling of the MedStream pump reservoir.
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham, MA 02767
Codman Neurosciences Sarl
Rue Girardet 29
2400 Le Locle
Reason for Recall:
Air in the pump reservoir may release a higher dosage of drug than expected, leading to drug overdose. This product may cause serious adverse health consequences, including low blood pressure (hypotension), an abnormally slow heart rate (bradycardia), loss of consciousness, and/or death.
Public Contact: For questions about this recall, contact Codman Neuro Clinical Support at 1-800-660-2660.
FDA District: New England District Office
On August 13, 2013, Codman & Shurtleff, Inc. sent a Medical Device Field Safety Notice Letter to US and International customers. The letter described the affected products, potential clinical impact, and updated the instructions for use (IFU) pump filling warning.
In addition, the letter informed customers that the IFU and product training materials had been updated by adding a warning statement about potential over dosage if air gets inside the pump reservoir and additional clarifications to reinforce the proper filling technique.
Customers were asked to do the following:
- Complete the Field Safety Notice Acknowledgement Form
- Return Form to local Codman Neuro Sales Representative or fax to: 508-977-6665
- Contact Codman Representative or Codman Neuro Clinical Support at 1-800-660-2660 for questions about the recall
- Report any malfunctions or adverse events related to the MedStream Programmable Infusion Pumps and refill kits to 1-866-491-0974 (choose option 2)
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.