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FDA designates recall of intra-aortic balloon pumps as class 1
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The FDA has designated Maquet/Datascope’s product recall of several intra-aortic balloon pumps as a class 1 recall, the most serious kind. The recall affects 22,853 devices used in patients undergoing cardiac and noncardiac surgery and for the treatment of patients with HF complications or ACS.
Battery issues in the four recalled models (Cardiosave Hybrid IABP, Cardiosave Rescue IABP, CS300 IABP, CS100/100i IABP) include failing to hold a charge, stopping unexpectedly and having shorter run times may cause the device to stop working when only working by battery, according to a MedWatch report from the FDA. The recall includes all manufacturing dates, lots and distribution dates. Patients with the intra-aortic balloon pump may be at risk for serious injury including death if the device does not work or if battery failure results in interrupted therapy.
The recall has been conducted to make sure that all users follow each device’s operating instructions manual on usage, maintenance, charging and storage of the batteries. The battery may not provide the expected minimum run time if battery maintenance as described in the instructions are not performed, according to the report.
Since March 2016, Maquet/Datascope received reports of five patient deaths, although it has not concluded whether they are associated with the device shutting down when operating only on battery power, according to the report.
Maquet/Datascope will contact all customers to schedule a training visit to learn more about battery operations, maintenance and care as detailed in a recently developed reference guide for each affected intra-aortic balloon pump. The company also distributed a notice to customers on June 17 alerting them of the potential risk for battery failure and actions to take to minimize patient harm, according to the report.
A battery maintenance software upgrade is currently being developed by Maquet/Datascope, which is scheduled to be released in early 2020, according to the report. A service representative will contact customers to schedule an installation of the software once it has been cleared by the FDA.
On Nov. 19, 2019, the FDA sent a letter to health care providers updating them on the recall. The agency advised that facilities using the product should review the company's notice about the recall and schedule a training session.
The agency also advised that users should follow each device's manual regarding battery matters, plug the device into an AC outlet during use whenever possible, plug the device into an AC outlet when not in use, fully charge the battery before transporting a patient, immediately replace Cardiosave Hybrid and Cardiosave Rescue batteries that are older than 4 years, follow all battery-related informational messages that appear on the device screen and report any event in which a device shuts down while running on batteries.