Recall Class: Class I
Date Recall Initiated: March 21, 2014
Products: Intra-Aortic Balloon Pumps (IABP), System 98/98XT, CS100/CS100i, and CS300, Model Numbers: 0998-00-0446-xx, 0998-UC-0446-xx, 0998-00-0479-xx, 0998-UC-0479-xx, 0998-UC-0446Hxx, 0998—00-3013-xx, 0998-UC-3013-xx, 0998-00-3023-xx, 0998-UC-3023-xx; and various lot numbers
Affected products were manufactured From January 1, 2003 through June 30, 2011 and distributed from January 17, 2003 through June 30, 2011.
Use: An intra-aortic balloon pump is a mechanical device that inflates a balloon placed in the patient’s thoracic aorta. The balloon inflates and deflates in order to help the heart pump blood, increase blood flow to the heart itself, and increase blood flow to the rest of the body. The device is used temporarily for emergency cardiac support conditions, such as after a heart attack, for severe heart failure, or while the patient is waiting for heart surgery.
Maquet Datascope Corporation
Cardiac Assist Division
45 Barbour Pond Drive
Wayne, New Jersey 07470
Reason for Recall:
The firm received 106 reports of device malfunctions. There were zero injuries and one death.
The firm determined that the fan assembly for the affected IABPs could contain a misshapen retaining ring. This retaining ring could separate within the fan assembly, causing the fan to stop rotating. This could result in the power supply overheating and the IABP would shut down without any warning.
This device failure would cause the balloon to stop inflating and deflating. It may result in decreased blood flow to the heart and the rest of the body, difficulty in weaning the patient from cardiopulmonary bypass, and clotting or blockage of blood vessels to the intestines, kidneys, or legs. The possible long range consequences of this include organ injury or tissue damage, possibly leading to patient death.
Public Contact: For customers with technical questions within the U.S., contact Technical Support at 1-800-777-4222 and press 3, Monday through Friday, between 8:00 a.m. and 6:00 p.m., Eastern Daylight Time.
FDA District: New Jersey District Office
More Information about this Recall:
On March 21, 2014, Maquet sent an Urgent Medical Device Field Correction letter to all affected customers. The letter identified the product, the problem, and the actions to be taken.
A recalled pump may continue to be used until a repair or replacement is performed. However, there should be heightened awareness that a sudden pump failure may occur without warning, and a backup pump should be available for immediate substitution in the case of a failure. If an alternative pump is unavailable and a failure occurs, the balloon should be removed from the patient as soon as possible according to standard procedures. This could result in added risk to the patient.
A Maquet Service Representative will contact customers with the affected IABPs to replace the fan assembly.
About Class I Recalls:
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.