More than 9,000 intra-aortic balloon pumps are being recalled, due to a risk of valve failures, which may cause serious side effects or death.
The Datascope Corp./Maquet intra-aortic balloon pump recall was posted by the FDA on August 4, after the manufacturer discovered the valve had a high risk of failure. This could cause the balloon pump to fail to inflate or deflate during use on a patient.
The FDA has categorized the action as a Class I recall, suggesting that continued use of the device poses a high risk of severe injury or death.
The intra-aortic balloon pump is a cardiac device used during or prior to cardiac surgery. It is initiated for patients with acute coronary syndrome or complications from heart failure.
A doctor threads the balloon pump into the aorta, the largest artery in the body, using a catheter. It is put into place to inflate and deflate with the natural pumping of blood in the heart to help the heart pump blood more effectively. It helps reduce the workload of a failing or critical heart. It also helps increase blood flow to the heart and the rest of the body.
If the valve of the intra-aorta balloon pump fails, the balloon may not inflate or deflate correctly. In this case, if a patient requires heart support with an intra-aortic balloon pump and the device does not work, the heart may not be able to fully pump blood to the rest of the body or the body may not receive enough blood.
If the balloon fails to function during use, a patient may experience serious and immediate side effects, such as cerebral embolism or death. The defect could also potentially cause the balloon to over-inflate, tearing the aortic valve.
The recalled Datascope intra-aortic balloon pumps were manufactured between July 22, 2003, and June 30, 2013, with distribution dates of March 24, 2003, to December 11, 2013. Overall, 9,194 devices were recalled with model/item numbers CS100i, CSO100, and CS300. This affects all devices in all lots manufactured before June 30, 2013.
Datascope announced a design change to the balloon pump in June 2017. However, not all devices manufactured prior to June 13, 2013 have been serviced and upgraded. Some may still be affected by the defect.
On June 19, 2017, Datascope sent “Urgent Product Recall Medical Device Field Correction” notices to customers. The notice informs customers of the risks of using the devices and lists actions to take to prevent patients from being harmed by the device, until the device can be serviced.
Those recommendations include:
- Check all inventory to identify affected units.
- Never leave the patient unattended during intra-aortic balloon pump therapy.
- Contact the company to schedule on-site service replacement of the defective solenoid driver boards, the defective part on the pump.
Healthcare providers may also conduct a self test on the pump, which takes 60 seconds. If the pump fails the test, the unit should be removed from service. If the pump passes, the healthcare provider may opt to continue using the pump until the repair can be made.
The company emphasized all medical facilities should weigh the risks and benefits before using the device on a patient when no other therapy is available and the unit has yet to be serviced for the recall problem.
Customers with questions can contact Datascope Corp./Maquet’s customer service department at (888)-627-8383 or send an email to [email protected].
Patients or healthcare providers who experience problems or side effects while using the pump should contact the FDA’s Medwatch Adverse Event Reporting Program.