Medscape

New Safety Questions Over Mechanical Circulatory Support

For circulatory support in cardiogenic shock, the best choice between Impella and intra-aortic balloon pump (IABP) has been controversial. Now, new data is complicating the debate. Presenting at the ...
TCTMD

FDA: Class I Recall for Cardiosave Hybrid IABP Due to ‘Fluid Ingress’

The US Food and Drug Administration (FDA) has alerted users of Datascope Corp/MAQUET’s Cardiosave hybrid intra-aortic balloon pump (IABP) to a “design issue” that enables fluids to leak into the ...
Medscape

FDA Spotlights Woes With Getinge’s Recalled IAB Pumps

The US Food and Drug Administration (FDA) is updating healthcare providers on device failures associated with Getinge’s Maquet/Datascope intra-aortic balloon pumps (IABPs), including the Cardiosave ...
Nasdaq

Teleflex Announces FDA Clearance Of AC3 Range Intra-Aortic Balloon Pump

(RTTNews) - Teleflex (TFX) announced FDA 510(k) clearance of the AC3 Range Intra-Aortic Balloon Pump. The AC3 Range IABP is designed to provide ongoing IABP support across various patient transport ...
The Globe and Mail

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 ...