FierceBiotech

FDA tacks Class I rating to Getinge recall of a decade’s worth of cardiac balloon pumps

Getinge has recalled nearly 8,800 heart devices after receiving more than 100 complaints about them, including one report of a patient death. The recall—which began in December and came though the ...
FierceBiotech

Amid CE mark suspension, Getinge cardiac balloon pumps hit with 2nd Class I recall this year

Just a week after Getinge temporarily lost CE mark clearance in Europe for its Cardiosave intra-aortic balloon pumps, the FDA has handed down a Class I recall rating to the devices—the second such ...
Nasdaq

Teleflex Receives FDA 510(k) Clearance of the AC3 Range™ Intra-Aortic Balloon Pump (IABP)

WAYNE, Pa., April 01, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced FDA 510(k) clearance of the AC3 Range™ Intra-Aortic ...
Healio

FDA designates intra-aortic balloon pump recall as class I

Please provide your email address to receive an email when new articles are posted on . The FDA announced it has designated a recall of intra-aortic balloon pumps by Datascope/Getinge as class I, the ...
Medscape

The Intra-aortic Balloon Pump in High-risk Percutaneous Coronary Intervention

IABP systems are typically inserted within the multidisciplinary environment that is the cardiac catheterization laboratory. The specific role of the physiologist during IABP insertion is to ensure ...
Becker's Hospital Review

Texas air crews train to transport patients with intra-aortic balloon pumps

Flight nurses and paramedics at AirLift Texas bases in Waco and New Braunfels, have been trained to use the Getinge cardiosave hybrid balloon pump device during air transport, according to a July 17 ...
Becker's Hospital Review

Getinge recalls intra-aortic balloon pumps over fluid leaks

Getinge is recalling 4,338 intra-aortic balloon pumps after discovering fluid leaks that can lead to unexpected shutdowns or the inability to initiate therapy, the FDA said Dec. 16. The agency has ...
Healio

FDA designates recall of two intra-aortic balloon pumps as Class 1

We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. The FDA has classified ...
Medscape

The Intra-aortic Balloon Pump in High-risk Percutaneous Coronary Intervention

"In short, it seems likely that the returned arterialized blood should be returned during diastole when the aortic valve is closed. This would probably offer less resistance to the ailing heart's ...