Dive Brief:
- Getinge subsidiary Maquet is recalling all intra-aortic balloon pumps over reports the batteries failed to hold a charge, stopped unexpectedly, and had shortened run-times, which can cause the devices to stop working when being operated in battery only mode. The recall was initiated on May 16.
- FDA classified the recall as Class I, the most serious type of recall, because use of the devices could cause injury or death. There have been five patients death since March 2016 but the firm hasn't determined the deaths were due solely to the devices shutting down while operating only on battery power.
- The products have been dogged by a series of problems over recent years, ranging from unexpected battery shutdowns to design flaws that allowed fluid to seep into the devices.
Dive Insight:
Maquet, a unit of Swedish device maker Getinge, is recalling a total of 22,853 the devices. IABPs are cardiac assist devices used in patients undergoing cardiac and non-cardiac surgery and to treat patients with acute coronary syndrome or complications from heart failure.
The company said it was recalling the devices to ensure users and servicers follow each device's manual for recommendations on usage, charging, maintenance and storage of the batteries. The battery run times and discharge cycles vary among models, the company said.
This isn't the first time the company has had to issue a recall for the devices unexpectedly shutting down. In 2018, the patient deaths following device shutdowns prompted FDA warnings and the company also initiated device recalls.
If a patient requires life-supporting therapy and the device does not work or if therapy is stopped during use due to battery failure, the patient will be at risk of serious injury, including death, the company said. Although the company recall didn't require return of any product, the company said it would contact each customer to schedule a training visit to review a recently developed battery care, maintenance and operations guide.
The company is also developing a Cardiosave battery maintenance software upgrade which is set for release in early 2020. The software update must be cleared by FDA, and, once it is cleared, a service representative would contact customers to schedule free installation of the updated software.
The device models recalled are Cardiosave Hybrid IABP, Cardiosave Rescue IABP, CS300 IABP and CS100/100i IABP.
Maquet acquired U.S.-based Datascope Corp., which was one of the leading makers of IABPs, in 2008. In recent years, the Maquet/Datascope unit has received far more 510(k) clearances for IABP devices than all other companies combined, but it is not the only business in the sector. In 2017, FDA cleared the use of another system from Arrow International. Both Maquet and Datascope are subsidiaries of Swedish medical technology company Getinge AB.
