Z-1940-2019Class I

Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use

Name: Z-1940-2019 Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use
Creator: Datascope Corp.
Published: 2019-06-17
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2019-06-17 / Open, Classified / root cause: labeling and UDI

FDA source

Datascope Corp. began a recall of Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use on 2019-06-17. FDA classified it as Class I and gives the reason as "If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1940-2019
Classification: Class I
Status: Open, Classified
Initiated: 2019-06-17
Posted: 2019-07-16
Recalling firm: Datascope Corp.
Product: Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
Root cause tag: labeling and UDI
FDA root cause: Use error
Action: On June 17, 2019, the firm notified its customers of the product issue via Urgent Medical Device Correction letters. Customers are to take the following immediate interim actions: " Ensure the IABP is plugged into an AC power outlet whenever possible during patient use to prevent the battery from depleting. " Ensure the IABP is plugged into an AC power outlet when the system is not in use. The batteries should be kept at a full charge even when the IABP is not in use. " When transporting patients within or between facilities, please refer to the IABP Operating Instructions Manual for recommendations on portable/battery operation. For example: " Prior to portable operation, the battery should be fully charged " For Cardiosave Rescue and Cardiosave Hybrid only: " Additional charged batteries should be on hand during transport " Ensure the batteries are properly seated in the battery compartment/charger and the IABP Console is completely seated/secured into the IABP Cart " For Cardiosave Hybrid, you can verify if the Console is completely seated in the IABP cart by the indicator on the display. Check battery run time and replace batteries as required, as recommended in each IABPs Operating Instructions Manual. A reduction in run time can occur over a battery's life for reasons such as age, storage temperature and discharge depth. Batteries should be replaced: " After reaching the maximum number of charge-discharge cycles " When the battery provides less than the minimum specified run time " If the battery is broken, cracked, leaking or damaged " When the labeled lifetime of the battery is reached NOTE: Batteries for the Cardiosave Hybrid and Cardiosave Rescue IABPs sold before June 2015 should be replaced immediately as the labeled lifetime for these batteries is 4 years. Replacement batteries can be ordered through your sales or service representative. To determine the date of manufacture for all Cardiosave batteries, refer to attached d
Quantity in commerce: 6,197
Distribution: Worldwide distribution. US Nationwide, AFGHANISTAN , HUNGARY , PANAMA , ALGERIA , ICELAND , PARAGUAY , ARGENTINA , INDIA , PERU , AUSTRALIA , INDONESIA , PHILIPPINES , AUSTRIA , IRAN , POLAND , AZERBAIJAN , IRAQ , PORTUGAL , BAHRAIN , IRELAND , QATAR , BANGLADESH , ISRAEL , ROMANIA , BELARUS , ITALY , RUSSIA , BELGIUM , JAPAN , SAUDI ARABIA , BOLIVIA , JORDAN , SERBIA , BOSNIA AND HERZEGOVINA , KAZAKHSTAN , SINGAPORE , BRAZIL , KENYA , SLOVAKIA , BRUNEI , KOSOVO , SLOVENIA , BULGARIA , KUWAIT , SOUTH AFRICA , CAMBODIA , LATVIA , SOUTH KOREA , CANADA , LEBANON , SPAIN , CHILE , LIBYA , SRI LANKA , CHINA , LITHUANIA , SWEDEN , COLOMBIA , LUXEMBOURG , SWITZERLAND , COSTA RICA , MACAU , SYRIA , CROATIA , MACEDONIA , TAIWAN , CYPRUS , MALAYSIA , TANZANIA , CZECH REPUBLIC , MALDIVES , THAILAND , DENMARK , MALTA , TRINIDAD , DOMINICAN REP , MARTINIQUE , TUNISIA , ECUADOR , MAURITIUS , TURKEY , EGYPT , MEXICO , TURKMENISTAN , EL SALVADOR , MOROCCO , UGANDA , ESTONIA , MYANMAR , UKRAINE , FINLAND , NAMIBIA , UNITED ARAB EMIRATES , FRANCE , NEPAL , UNITED KINGDOM , GEORGIA , NETHERLANDS , URUGUAY , GERMANY , NEW ZEALAND , UZBEKISTAN , GHANA , NIGERIA , VENEZUELA , GREECE , NORTH KOREA , VIETNAM , GUATEMALA , NORWAY , YEMEN , GUYANA , OMAN , ZAMBIA , HONDURAS , PAKISTAN , HONG KONG , and PALESTINE.
Product codes and lots: All serial numbers affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1940-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1939-2019	Class I	Ongoing	Voluntary: Firm initiated	2019-07-24	2019-07-15
Z-1940-2019	Class I	Ongoing	Voluntary: Firm initiated	2019-07-24	2019-07-15
Z-1941-2019	Class I	Ongoing	Voluntary: Firm initiated	2019-07-24	2019-07-15
Z-1942-2019	Class I	Ongoing	Voluntary: Firm initiated	2019-07-24	2019-07-15
Z-1943-2019	Class I	Ongoing	Voluntary: Firm initiated	2019-07-24	2019-07-15
Z-1944-2019	Class I	Ongoing	Voluntary: Firm initiated	2019-07-24	2019-07-15

Product code DSP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)