The United States Food and Drug Administration (FDA) has revealed that Getinge subsidiary Datascope is recalling specific Cardiosave intra-aortic balloon pumps (IABPs) due to an increased likelihood of the devices ceasing operation without warning.
The unplanned shutdowns result from communication problems between the device’s executive processor printed circuit board assembly (PCBA) and video generator PCBA.
“Without any warnings or alarms, the shutdown will take place,” the FDA’s advisory states. “To restore the device’s functionality, one or both of the PCBAs must be replaced once the error occurs.”
The advisory cautions that unexpected IABP shutdowns may lead to severe complications, such as organ damage or even fatality. Although 42 complaints have been received about the PCBA issues, no serious injuries or deaths have occurred.
This recall— the third in as many months for these devices— affects both the Cardiosave Hybrid IABP and the Cardiosave Rescue IABP. From March 2012 to January 2023, a total of 4,502 IABPs distributed to customers were involved.
Previous Concerns with Cardiosave Intra-Aortic Balloon Pumps
The Cardiosave Hybrid and Rescue IABPs have faced safety challenges for several years. This marks the third recall in 2023 alone. In January, specific devices were recalled due to blood entering the IABPs through a damaged catheter. At the time of the recall, 134 issues had been reported, including four severe injuries and one patient death.
The recall announced on March 17, similar to the most recent recall, was prompted by the risk of devices turning off without any warning. At the time of the recall, 44 customer complaints had been filed, but no serious injuries or fatalities had occurred.
Furthermore, TÜV SÜD, a German firm that acts as a notified body for medical devices sold and distributed in Europe, declared in March that it is suspending the CE mark for Getinge’s Cardiosave IABPs for three months. During this temporary suspension, Getinge and its subsidiaries are prohibited from selling the affected devices to customers in countries that require the certificate.
Intra-aortic balloon pumps (IABPs) are small devices used to provide temporary mechanical support to the heart in individuals with certain heart conditions. They consist of a long, thin tube with a balloon at the end that is inserted through a blood vessel in the groin or arm and advanced to the aorta, the large artery that carries oxygenated blood from the heart to the rest of the body. The balloon is then inflated and deflated in synchrony with the heartbeat, assisting the heart in pumping blood to the body’s organs and tissues.
IABPs are commonly used in individuals with severe heart failure, cardiogenic shock, or other conditions that impair the heart’s ability to pump blood effectively. They may also be used before or after certain heart surgeries or procedures to support the heart and reduce the risk of complications.
While IABPs can provide significant benefits in certain situations, they are not appropriate for all individuals and may be associated with certain risks and complications. As such, the decision to use an IABP should be made on a case-by-case basis by a qualified healthcare professional.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
To find out if you or your loved one can file a Cardiosave IABP Injury or Wrongful Death Lawsuit, call Parker Waichman LLP for a free legal consultation. Call 1-800-YOUR-LAWYER (1-800-968-7529) or use our online chat feature to speak with our Cardiosave Intra-Aortic Balloon Pump Lawsuit Attorneys, who will help you understand your rights and work hard to obtain the compensation you or your loved one deserves.
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