MedStream Programmable Infusion Pump and Refill Kits by Codman and Shurtleff: Class 1 Recall - Drug Over Infusion

AUDIENCE: Risk Manager, Healthcare Professional 

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 death.

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 affected 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:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm
• Download¹ and complete the form, then submit it via fax at 1-800-FDA-0178.