More than 20,000 cardiac assist devices used in hospitals nationwide have been recalled, due to a risk that the battery may lose charge and stop working unexpectedly, which may have been linked to at least five patient deaths.
The FDA announced the Maquet/Datascope Intra-Aortic Balloon Pump recall on July 23, indicating that design defect in the batteries used to power the devices may cause the device to be prone to losing charge, stopping unexpectedly, and having shortened run-time. These problems may cause the balloon pump to stop working.
To date, the manufacturer has become aware of five patient deaths while using the recalled devices. However, an investigation is still ongoing to determine whether the battery failure defect contributed to the fatalities.
Intra-Aortic Balloon Pumps (IABP) are cardiac assist devices used during patient cardiac and non-cardiac surgeries. The devices are also used to treat patients with acute coronary syndrome or complications from heart failure.
FDA officials are warning healthcare professionals that patients using IABP devices for life-supporting therapy may be at an increased risk of severe injuries or death in the event the battery experiences complications during use.
The recall includes all lot numbers of the Cardiosave Hybrid IABP, Cardiosave Rescue IABP, CS300 IABP and CS100/100i IABP models manufactured by Maquet/Datascope of Wayne, New Jersey. The devices were distributed for sale across the United States to medical centers and hospitals.
On June 17, 2019, the manufacturer issued an Urgent Medical Device Correction notice informing customers of the potential risk of battery failure, and listed a series of instructions to follow to ensure patient safety.
The manufacturer recall notice warns that customers should ensure the IABP is plugged into an AC power outlet when the system is not is use, and whenever possible during patient use. The battery run time should be checked frequently and replaced with only Datascope-approved replacement batteries, as recommended in the Operating Instructions Manual.
Maquet/Datascope announced they are currently working on developing a Cardiosave battery maintenance software upgrade, expected to be ready in early 2020. Once the software upgrade is cleared by the FDA, the manufacturer will begin notifying customers to schedule the installation.
The FDA has categorized this recall as a Class I, indicating it is the most serious type of recall and that the use of these devices may cause serious injuries or death to patients.
Customers with additional questions or concerns regarding the recall may contact Maquet/Datascope Technical Support Department at 1-888-627-8383. All adverse events involving the recalled devices should be reported to the FDA’s MedWatch Adverse Event Reporting Program.