Datascope Corp.: CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.

Recall number

Z-1944-2019

Recalling firm

Datascope Corp.

Product

CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.

Status

Open, Classified

Initiated

2019-06-17

Posted

2019-07-16

Terminated

not on file

Reason

If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.

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

16,656

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.

Lot, serial or model codes

All serial numbers affected

510(k) numbers

["K151254"]

PMA numbers

not on file

Product code

DSP

Firm FEI

3001418283

Firm city

Mahwah

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy