Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.

Recommended Action

Per FDA guidance

An URGENT FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION notification letter was sent to customer on 5/4/23. Actions to be taken by the customer: " Please locate the CARDIOSAVE Hybrid IABPs with the serial numbers listed in this notice. " Please ensure that all Cardiosave Hybrid Intra-Aortic Balloon Pump users at your facility are aware of this notice. " Please forward this information to all current and potential Cardiosave Hybrid IABPs users within your hospital / facility. " Please contact your local Getinge Service Representative to arrange to have the affected IFU USB drives replaced. " Please complete and sign the attached URGENT FIELD SAFETY NOTICE RESPONSE FORM (page 3) to acknowledge that you have received this notification. Return the completed form to Datascope Corp./Getinge by e-mailing a scanned copy to fieldaction@getinge.com Actions to be taken by Getinge: Getinge will provide your facility with an updated IFU USB drive that contains reference to the vibration testing standard, 60601-1-12:2014. The original USB drive that was provided during the D.00 software update can be destroyed locally. This voluntary correction notification only affects the products listed on page 1; no other products are affected by this voluntary correction. We apologize for any inconvenience this Medical Device Correction may cause. If you have any questions, please contact your Datascope Corp./Getinge representative.

Distribution

As reported by FDA

IN