The warning covers Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and the Getinge/Maquet Cardiohelp system and HLS sets.
“The FDA continues to receive medical device reports (MDR) related to the problems even though Getinge/Maquet took corrective steps,” the agency said.
Those steps included providing new actions for IABP users and reinforcing information in device instructions for use.
“The FDA recommends that health care facilities transition away from use of these devices and seek alternatives, if possible,” the agency said. “These recommendations are based on our continued concerns that Getinge/Maquet has not sufficiently addressed the problems and risks with these recalled devices.”
Because alternate treatment options are limited, the FDA offered recommendations for continued use of the affected Getinge cardiovascular devices when neccessary. Those recommendations include planning to obtain alternate equipment, reviewing the FDA’s previous recommendations and the latest recall information, and reporting issues and adverse events and supply chain issues.
“We take this seriously and are in close ongoing dialogue with the FDA to address the concerns in the best possible way,” Getinge Acute Care Therapies President Elin Frostehav said in a statement shared by the company.
Getinge’s Cardiosave and Cardiohelp recalls
Getinge initiated 12 voluntary recalls for the Cardiosave IABP From Jan. 1, 2023, through April 11, 2024, including eight classified by the FDA as Class I recalls, the most serious type.
The FDA said it has received 2,964 MDRs related to Cardiosave IABPs in the last 12 months, including 15 that reported serious injury or death.
“The FDA continues to receive adverse event reports related to the failures associated with Cardiosave recalls,” the agency said. “Since 2017, the FDA has been evaluating and monitoring MDRs that describe Cardiosave IABP devices shutting down. The FDA has also been evaluating other concerns with the Cardiosave IABP, including blood entering the device, which can cause the IABP to rupture (helium emboli) or the patient or health care provider being exposed to patient blood.”
Getinge has also initiated eight voluntary recalls for the Cardiohelp system and HLS set from Jan. 1, 2023, through April 11, 2024, including one Class I recall.
The FDA said it has received 246 MDRs related to the Getinge Cardiohelp System and HLS set, including 33 that reported serious injury or death.
“The FDA continues to have concerns regarding the sterility of the HLS set,” the agency said. “Sterility was also a concern in May 2023, when Getinge notified U.S. customers that it removed another of its cardiopulmonary bypass devices, the Quadrox oxygenators, from the U.S. market. The Quadrox oxygenators continue to be unavailable because of sterility issues.”
The FDA said it is working with Getinge “to understand factors contributing to the device failures, as well as possible mitigation strategies,” and also working with other manufacturers to make more alternative devices available.
Getinge manufacturing sites have been under a federal consent decree through the U.S. Department of Justice and FDA since 2015. The IABP manufacturing site was added to the consent decree in 2022.
“This action allows additional FDA oversight, an independent auditor, inspections, and updates on progress made toward addressing quality and safety concerns,” the FDA said. “At this time, the cardiopulmonary bypass and IABP facilities have not met the requirements to have the consent decree lifted.”
This post was originally published on May 8, 2024, and updated on May 9 with comment from Getinge.
