Intra-aortic balloon pump recall designated class I by FDA
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Datascope/Getinge announced a recall of its intra-aortic balloon pumps due to risk for blood entering the pump through a damaged balloon catheter — also called a blood back event — and causing harm to the patient.
The FDA identified the recall of these devices (Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps) as class I, the most serious type of recall.
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These devices are indicated for ACS, cardiac and noncardiac surgery or complications of HF in adult patients, according to the FDA release.
A blood back event may lead to complications including unexpected pump shutdown; helium gas emboli releasing into the patient’s blood; patient blood loss; user and/or maintenance personnel exposure to an unexpected biohazard; or blood cross-contamination if the affected pump is not evaluated before use with a new patient.
The recall affects 4,454 devices distributed between March 6, 2012 and the present. The company reports receiving 134 complaints about this issue, including 12 device shutdowns and five adverse events resulting in four serious injuries and one death.
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