ISSUE: FDA and Codman & Shurtleff, Inc. notified
healthcare professionals of the class 1 recall of MedStream Programmable Pump
and MedStream Refill Kit due to air in the pump reservoir which 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
BACKGROUND: 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. On August 13,
2013, Codman & Shurtleff, Inc. sent a Medical Device Field Safety Notice
Letter to US and International customers. The affected products were
manufactured from March 2009 to September 2012 and distributed from January 08,
2010 to July 19, 2013. Please refer to Class 1 Recall Notice for Product Codes
and link to Letter.
RECOMMENDATION: 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).
Health care providers and consumers may
report adverse events or quality problems experienced with the use of any Main
Street products to the FDA’s MedWatch Adverse Event Reporting program:
Read the MedWatch Safety Alert, including a
link to the Class 1 Recall Notice here.
Source: U.S. Food and Drug Administration (FDA) (Accessed: 10/22/2013)