Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-1146-2023 · Posted 2023-03-09

Recalling FirmDatascope Corp.
Recall StatusOpen, Classified
Product CodeDSP
Date Initiated2023-02-07
Product Quantity4062 Total

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.

Firm Action

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

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112372CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMPCardiac Assist, Maquet Cardiovascular, LLC · 2011-09-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑