March 20, 2023 — According to a statement issued by the U.S. Food and Drug Administration (FDA), Datascope, a subsidiary of Getinge, is recalling Cardiosave Hybrid IABPs and Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown. This shutdown will occur without warnings or alarms to alert the user. The issue may occur in units distributed before July 24, 2017.
The devices are designed to help the heart pump more blood and an unexpected pump shutdown and any interruption to therapy can lead to unstable blood flow, organ damage, including death, especially for people who are critically ill.
Datascope has reported 44 complaints about damaged coiled cords resulting in unexpected shutdowns from June 2019 to August 2022, the FDA said, adding that there have been no reports of injuries or deaths related to this issue.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
- Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP)
- Product Models:
- Distribution Dates: March 6, 2012 to July 20, 2017
- Devices Recalled in the U.S.: Estimated 2,300
- Date Initiated by Firm: January 9, 2023
The Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and the Cardiosave Rescue IABP are electromechanical systems used to inflate and deflate intra-aortic balloons. These systems provide temporary support to the left ventricle through counter pulsation. Once the balloon is positioned in the aorta, the pump is set to work in synchrony with the electrocardiogram or arterial pressure waveform to make the balloon inflate and deflate at the right time during the cardiac cycle.
Cardiosave Intra-Aortic Balloon Pumps are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults. They are used in health care facilities.
Reason for Recall
Datascope, a subsidiary of Getinge, is recalling Cardiosave Hybrid IABPs and Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown. This shutdown will occur without warnings or alarms to alert the user. Once the error occurs, the coiled cord needs to be replaced for the device to work again. The issue may occur in units distributed before July 24, 2017.
An unexpected pump shutdown and any interruption to therapy that occurs can lead to unstable blood flow (hemodynamic instability), organ damage and/or death, especially for people who are critically ill and most likely to receive therapy using these devices.
From June 2019 to August 2022, Datascope/Getinge has reported 44 complaints about damaged coiled cords resulting in unexpected shutdowns. There have been no reports of injuries or deaths related to this issue.
Who May be Affected
- People who receive circulatory support using a CardioSave Hybrid or Rescue IABP (units distributed prior to July 24, 2017, and/or coiled cord part number 0012-00-1801)
- Health care personnel providing care that includes the CardioSave Hybrid or Rescue IABP
- Maintenance or service personnel providing service to the CardioSave Hybrid or Rescue IABPs
What to Do
On February 7, 2023, Datascope/Getinge sent customers an Urgent Medical Device Correction letter. The letter offered the following clinical guidelines and user actions related to the coiled cord connection issue as part of a list of several notifications.
Coiled Cord Connection Failure Clinical User Actions
- Inspect the coiled cable cord of the Cardiosave IABP for visible damage prior to use.
- If an unexpected shutdown occurs:
- Attempt to restart the Cardiosave IABP until an alternative pump is available.
- If the restart attempt is unsuccessful, use another IABP to continue therapy.
- If the device remains inoperable after a shutdown:
- Remove it from patient care.
- Contact a service representative to identify the cause and take necessary actions.
Coiled Cord Connection Failure User Actions
- Examine inventory immediately to identify any Cardiosave Hybrid and/or Rescue IABPs with the affected coiled cord.
- Ensure that all Cardiosave Intra-Aortic Balloon Pump users are aware of this notice and actions to perform.
- Complete and sign the MEDICAL DEVICE CORRECTION – RESPONSE form included with the letter to acknowledge receipt of notification. Return the completed form to Datascope/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to 1-877-660-5841.
- Distributors should forward the letter to any customers who received affected products.
The letter states that this issue is limited to units distributed prior to July 24, 2017. Datascope/Getinge has developed a hardware correction to address this issue, and a service representative will contact customers to schedule installation of the correction when the correction kit is available.
Customers with questions about this recall should contact their Datascope/Getinge representative or call Datascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).