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Cardiosave Recalls and MDRs

2024-04-26
  • From January 1, 2023 through April 11, 2024, Getinge initiated 12 voluntary recalls in the U.S. for the Cardiosave IABP. Of these, the FDA classified eight as a Class I recall, the most serious type of recall. In the last 12 months, the FDA has received 2,964 medical device reports (MDR) related to Cardiosave Intra-Aortic Balloon Pumps.   Of those, 15 were reported as resulting in patient serious injury or death. As a general matter, MDRs are one of the FDA’s several postmarket surveillance tools used to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments during real world use. It may be difficult to confirm a direct cause and effect between an adverse event report and a specific medical device based on the limited information provided in the reports.

  • The FDA continues to receive adverse event reports related to the failures associated with Cardiosave recalls. 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.

  • In addition, on March 1, 2024External Link Disclaimer, TÜV SÜD, the European Union notified body for certification services, temporarily suspended the CE certificate (CE marking means that products have Conformité Européenne or European conformity certification) for Getinge’s Cardiosave Intra-Aortic Balloon Pump with immediate effect.   Getinge is given six months to adhere to the required corrective actions, and during this time, the Intra-Aortic Balloon Pumps cannot be sold in countries that require CE certification.   This only impacts the Cardiosave devices.


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