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New Jersey-based Datascope Corporation has issued a voluntary recall of the Maquet Intra-Aortic Balloon Pump System 98/98XT. The U.S. Food and Drug Administration officially issued the Class I recall on June 16, 2017. The defective medical device affects 9,194 patients in the United States. The company, located in Wayne, New Jersey, entered the recall after learning of 106 IABP malfunctions. There has been one known fatality resulting from the defective medical device. A Class I recall is the most serious case that the FDA issues; the classification means that there is an immediate and significant risk of fatality with continued use.
The intra-aortic balloon pump is a mechanical device inserted into the thoracic aorta. The device inflates and deflates a balloon to help the heart pump blood and maintain adequate blood flow. It is most often used after a heart attack or related cardiac failure for emergency maintenance until the performance of more extensive heart surgery.
Datascope found that the Maquet System 98/98XT has a design flaw which causes shutdown of the pump that controls air supply to the balloon. A retaining ring within the fan assembly is misshapen and tends to separate from the device causing the fan to stop functioning. This results in overheating of the power supply and eventual shutdown of the unit without warning.
The Class I recall affects the following model numbers:
The defective devices include all lot numbers prior to June 30, 2013. The Class I recall affects units manufactured between July 22, 2003 and June 30, 2013, with distribution dates ranging from March 24, 2003 to December 11, 2013.
When a Class I recall occurs, the FDA and manufacturer work together to determine how best to protect patients affected. Sometime after June 19, 2017, patients with the defective medical device should have received a notice titled, “Urgent Product Recall Medical Device Field Correction.” This notice contained instructions for patients related to risks and included recommended actions until a service team can repair or replace the device.
For patients who did not receive the notice, they advise that anyone with the Maquet System 98/98XT never be unattended. There are additional steps medical professionals can take to further safeguard patients until a service team can help. Patients may also contact Datascope customer service at 1-888-627-8383 for more information.
Another step a patient may take if they learn they are living with the Maquet System 98/98XT IABP is to contact an experienced medical product liability lawyer. Your lawyer can see to it that Datascope provides timely assistance and help you recover damages resulting from harm caused by the defective medical device.
Any recall of a medical device is serious, but the Maquet IABP is the most severe possible. Patients are at great risk if they do not take immediate steps to protect themselves. The situation is urgent and the Philadelphia medical product liability lawyers at Brookman, Rosenberg, Brown & Sandler are here to help. Datascope Corporation voluntarily recalling the defective units does not excuse them from liability. Contact us online or call us today at 215-569-4000 or 800-369-0899. We help patients from Philadelphia, Pennsylvania and New Jersey, including Chester County, Delaware County, and Philadelphia County.