FDA Expands Datascope IABP Field Correction to Class I Recall

September 06, 2017

SILVER SPRING, MD —The US Food and Drug Administration has expanded the June 2017 onsite field correction issued for Datascope/Maquet intra-aortic balloon pumps (IABPs) to a class I recall, the agency has announced[1].

The action applies the company's CS100i, CS100, and CS300 IABP series in lots manufactured since July 2003 and sold in the US, which the agency pegs at 5049 units. That's a broader period than was covered by the previous field correction notice, which did not apply to IABP devices sold after December 11, 2013.

The cited problem with the devices is a "false blood-detection alarm and ingress of fluid" into the IAB, the FDA says. "If a patient requires circulatory support with an IABP and the device does not work or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death."

The agency provided technical instructions for providers with the affected devices pending on-site service by the manufacturer to correct the problem.

Recalls and field corrections have beset Datascope/Maquet IABP systems before, including in June 2011 involving malfunctioning fans potentially causing the systems to overheat and shut down unexpectedly.

Follow Steve Stiles on Twitter: @SteveStiles2. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.