IABPs recalled due to malfunctions at high altitudes

The FDA announced that Getinge issued a voluntary recall of two intra-aortic balloon pumps due to interruption or inability to start therapy at high altitudes.

The recall involves 5,223 Maquet/Getinge Cardiosave intra-aortic balloon pumps (IABPs) sold by Datascope Corp. because of difficulties with starting or continuing use of certain intra-aortic balloons utilized with the IABP at altitudes above 3,200 ft, or 975 m. If that happens, hemodynamic instability could result, according to the announcement.

The Cardiosave Hybrid and Rescue IABPs are affected, but the CS100 and CS300 IABPs are not, the FDA stated. No adverse events or deaths related to the issue have yet been reported.

The alert includes instructions about when it is appropriate to use the following balloons with the affected IABPs: Sensation 34 cc and 40 cc; Sensation Plus 40 cc and 50 cc; Mega 30 cc, 40 cc and 50 cc; Linear 25 cc, 34 cc and 40 cc; TransRay 34 cc and 40 cc (Japan only); TransRay Plus 35 cc and 40 cc (Japan only); and Yamato Plus N or R 30 cc, 35 cc and 40 cc (Japan only).

According to the announcement, Maquet/Getinge is issuing a software correction to fix the problem, which is expected to be ready in February. Affected customers will be contacted about installing the new software.