Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbe

FDA device recall Z-1145-2023 · posted 2023-03-09 · Open, Classified

Recall details

Recalling firm

Datascope Corp.

Reason for recall

An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit.

Action taken

The firm sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 2/7/23 to customers. The customers were instructed to do the following actions: Examine your inventory immediately to determine if you have any Cardiosave Hybrid and/or Rescue IABPs. Prior to use of the Cardiosave IABP, inspect the coiled cable cord to ensure that there is no visible damage. Should you experience an unexpected shutdown of the Cardiosave IABP during therapy, or a present frozen or black screen, utilize another IABP to continue therapy. Until an alternative IABP is located you may attempt to restart the IABP. If the IABP remains non-operational, immediately remove from the patient care environment for further product evaluation. During Installation and Replacement of the Helium Tank per the Cardiosave Operating Instructions, please ensure care is taken not to damage the helium tank or the helium tank yoke while inserting and/or removing the helium tank. Follow the instructions for use when changing the helium tank. If user observes any visual damage to the O-ring installed as part of the quick disconnect fitting, contact your Datascope/Getinge service representative. If your device remains inoperable, please contact your service representative to identify the cause and take the necessary actions required. Complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM to acknowledge that you have received and understand this notification. Return the completed form to Datascope/Getinge by e-mailing a scanned copy to cardiosave-sdhl23.act@getinge.com or by faxing the form to 1-877-660-5841. If you have any questions, please contact your 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). Type of Action by the Company: Datascope/Getinge has developed a hardware correction to address this issue. It is important to note that this i

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DSP

Quantity affected

4062 Total

Distribution

Worldwide Distribution: US (nationwide) and OUS (Foreign) ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, BRUNEI , BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, ECUADOR

Date initiated

2023-02-07

Date posted

2023-03-09

Location

Mahwah, NJ

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