MedStream Infusion Pump Recalled over Defect that Can Raise DosageOct 24, 2013
The U.S. Food and Drug Administration (FDA) and Codman & Shurtleff, Inc. have notified healthcare professionals that the company’s MedStream Programmable Pump and MedStream Refill Kit were issued a Class 1 recall. Air in the pump reservoir may result in the release of a higher dosage of drug than expected, which could lead to serious adverse health consequences, including low blood pressure (hypotension), an abnormally slow heart rate (bradycardia), loss of consciousness, and/or death.
The MedStream Programmable Infusion Pump is an implanted drug delivery system used in the delivery of Baclofen to treat muscle symptoms. Refill kits are used to fill and refill the MedStream pump reservoir. On August 13, 2013, Codman & Shurtleff, Inc. sent a Medical Device Field Safety Notice Letter to U.S. and international customers. The affected kits were manufactured from March 2009 to September 2012 and distributed in the U.S. and internationally from January 8, 2010 to July 19, 2013. A full list of the latest recalled products can be found on the FDA website.
A Class I recall is the FDA’s most serious category, reserved for “situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
For questions about the recall, consumers and health care providers may contact Codman & Shurtleff at 1.800.660.2660. To report malfunctions or adverse events related to the MedStream Programmable Infusion Pumps and refill kits, call 1.866.491.0974 (choose option 2).
Health care providers and consumers may report adverse events or quality problems experienced with these products to the FDA’s MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm.