FDA Deems ‘Field Action’ for Faulty IABPs a Class I Recall

The US Food and Drug Administration (FDA) has classified an earlier recall and field correction of certain intra-aortic balloon pumps (IABPs) as a Class I recall, saying the failure of the device valve could lead to “immediate and serious adverse health consequences, including death.”

TCTMD reported previously on the action undertaken by Datascope/Maquet back in June, noting that the company was sending service representatives to repair the devices on-site. The new notice alerts physicians and patients to the fact that they have deemed the earlier recall to be Class I, the most serious category.

According to the FDA, 9,194 IABPs have been recalled in the United States. As previously reported by TCTMD, the action affects three models—the CS100i, CSO100, or CS300 manufactured before June 30, 2013, and not serviced or upgraded to fix the problem. While the original company-issued field correction described “electrical test failure” affecting how power is transmitted to the device valve, the more recent notice from the FDA speaks more generally about device “valve failure,” which can prevent the balloon from inflating and deflating properly.

The manufacturer is providing hospitals with specific actions they can take if they do not have an alternate IABP to use, starting with gauging the risk/benefit trade-off of using the affected device before it can be fixed. Among the recommendations are that no patient should be left unattended during IABP therapy and the importance of making sure the IABP is powered on prior to insertion of the catheter to allow the IABP to complete its self-test, a process that takes less than 60 seconds.

A press release issued by Maquet states that the company has received a complaint of a patient death, due to the failure of the device to initiate therapy.