Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
- Company
- Datascope Corp.
- Recall Initiated
- February 7, 2023
- Posted
- March 9, 2023
- Recall Number
- Z-1148-2023
- Quantity
- 4793 (US); 4407 (OUS)
- Firm Location
- Mahwah, NJ
Reason for Recall
An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP.
Distribution
Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WV; and OUS (Foreign) countries of: ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BARBADOS, BELRUS, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, C¿te d'Ivoire, CROATIA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE,GERMANY,GHANA,GUATEMALA,HONG KONG,HUNGARY,ICELAND,INDIA,INDONESIA IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOSOVO, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO TUNISIA, TURKEY, TURKMENISTAN, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM UZBEKISTAN, VIETNAM, YEMEN AND ZAMBIA.
Lot / Code Info
Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449 All serial numbers
Root Cause
Software design
Action Taken
On February 7, 2023, the firm notified customers of 4 issues affecting the IABP via an urgent Medical Device Correction letter, which included the present issue. Users were instructed to do the following: 1. If you experience an unexpected shutdown of Cardiosave IABP during therapy, or a frozen or black screen, use 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. 2. If your device remains inoperable, please contact your service representative to identify the cause and take the necessary actions required. The firm is developing a software correction to address the issue. Once available, a Datascope/Getinge service representative will contact you to schedule the installation of the updated software. This work will be done at no cost to your facility. If you have any questions, please contact your Datascope/Getinge representative or call the 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).