Moog Curlin Ambulatory Infusion Pump Recall Classified as Class I Recall

Federal health regulators have determined that several models of recalled Curlin Ambulatory Infusion Pumps by Moog Inc., which contain a software problem that could cause them to shut down unexpectedly, pose a substantial risk of serious injury or death if the are used. 

The Curlin infusion pump recall was classified as a Class I medical device recall by the FDA on April 8, which is the agency’s most serious recall category. A Class 1 recall designation is only used when there is a reasonable probability that the use of a product will cause serious adverse health consequences or death.

The recall was issued because the infusion pumps have a software anomaly that causes an error code to appear and causes the pump to shut down. Although there have been no reports of injuries or deaths connected to the infusion pump recall, a shut down can stop or delay critical drug therapy, which could injure or kill the patient.

The recall affects the Moog Inc. Curlin 6000 CMS, Curlin 6000 CMS IOD, PainSmart, and PainSmart IOD ambulatory infusion pumps. All of the affected models were manufactured and updated between May 2007 and February 2011.

Last year, the FDA announced a new initiative to address safety problems with infusion pumps, which have been linked to more than 56,000 adverse event reports over the past five years, including at least 500 deaths. According to FDA data, there were 87 infusion pump recalls between 2005 and 2009 to address identified safety concerns.

Customers who have the affected pumps are being notified by Moog Inc. through certified mail. Moog Inc. recommends that anyone who sees an Error Code 45 should return their pump to Moog. Customers with questions can call 1-800-970-2337.