Datascope/Getinge has issued a recall of specific Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) due to a potential shutdown risk from Coiled Cord Connection Failure leading to death. On 03/17/2023, The U.S. FDA classified the recall as a Class I Recall, the most severe type of recall. A Class I Recall means the usage of these devices could result in severe injury or death.
The recalled products’ names are the Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) and the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP). These medical devices were distributed from March 6, 2012, until July 20, 2017. According to the recall announcement, there are about 2,300 devices subject to this recall.
The Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue IABP are electromechanical devices designed to inflate and deflate intra-aortic balloons. These systems temporarily support the left ventricle through counterpulsation. The pump is set to work in sync with the electrocardiogram or arterial pressure waveform once the balloon is positioned in the aorta, ensuring proper inflation and deflation during the cardiac cycle.
Cardiosave Intra-Aortic Balloon Pumps are intended for:
- acute coronary syndrome,
- cardiac and non-cardiac surgeries, and
- complications of heart failure in adults.
They are only used in healthcare facilities.
The Reason for Recall
Datascope, a Getinge subsidiary, is recalling Rescue IABPs and Cardiosave Hybrid IABPs because the coiled cable connecting the display and base on some devices may fail, leading to an unexpected shutdown. This shutdown will happen without any warning signs or alarms. To restore the device’s functionality, the coiled cord must be replaced. This issue may occur in devices distributed before July 24, 2017.
An unexpected pump shutdown and any resulting therapy interruption can cause unstable blood flow (hemodynamic instability), organ damage, and/or death, particularly for critically ill patients who are most likely to receive therapy using these devices.
Between June 2019 and August 2022, Datascope/Getinge received 44 complaints about damaged coiled cords causing unexpected shutdowns. There have been no reported injuries or deaths related to this problem.
The Affected Parties
Individuals receiving circulatory support using a CardioSave Hybrid or Rescue IABP (devices distributed before July 24, 2017, and/or coiled cord part number is 0012-00-1801) Healthcare personnel providing care that involves the CardioSave Hybrid or Rescue IABP Maintenance or service staff servicing the CardioSave Hybrid or Rescue IABPs.
The FDA’s Recommended Actions
On February 7, 2023, Datascope/Getinge sent out an Urgent Medical Device Correction letter to patients and providers. The letter provided the following user actions and clinical guidelines related to the coiled cord connection problem as part of several notifications.
Coiled Cord Connection Failure Clinical User Actions
- Examine the Cardiosave IABP’s coiled cable cord for visible damage before use.
- If an unexpected shutdown occurs: Try to restart the Cardiosave IABP until a different pump is available.
- If restarting is unsuccessful, use another IABP to continue treatment.
- If the device continues to be inoperable after a shutdown: Remove it from patient care. Contact a service representative to determine the cause and take appropriate action.
Coiled Cord Connection Failure User Actions
Immediately inspect inventory to identify any affected Cardiosave Hybrid and/or Rescue IABPs with the problematic coiled cord. Ensure all Cardiosave Intra-Aortic Balloon Pump users are informed of this notice and the actions to take. Fill our and sign the “Medial Device Correction – Response” form included with the letter to confirm receipt of notification. Return the form to Datascope/Getinge by emailing or faxing the form. Distributors should also forward the letter to any customers who received recalled products. The letter says that this problem is limited to units distributed before July 24, 2017.
Datascope/Getinge has created a hardware correction to fix this issue, and a service representative will reach out to customers to schedule the installation of the fix once the correction kit is available.
Customers who have questions about the recall should call their Datascope/Getinge representative or call Datascope/Getinge Technical Support between 8:00 AM and 6:00 PM (Eastern Time Zone). The contact information can be found on the company’s website https://www.getinge.com/int/contact/.
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