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Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)… recallZ-1146-2023 · Datascope Corp. · initiated Feb 7, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Datascope Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected] 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

Recall details

Recall number
Z-1146-2023
Status
Open, Classified
Initiated by the company
Feb 7, 2023
Posted by the FDA
Mar 9, 2023
Recalling firm
Datascope Corp.
Quantity
4062 Total
Product code
DSP
FDA submissions
K112372
Distribution
Worldwide Distribution: US (nationwide) and OUS (Foreign) ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, BRUNEI , BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GHANA, HONG KONG, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NETHERLANDS, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, TURKMENISTAN, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM, AND YEMEN.

Product description

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Code information (models, lots, serial numbers)

All serial numbers. Model Number 0998-00-0800-75, UDI-DI 10607567112312; Model Number 0998-00-0800-83, UDI-DI 10607567108407; Model Number 0998-00-0800-85, UDI-DI 10607567113449

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 91602).

Sources and updates

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