Datascope Corp.: Medical Device Recall in 2019 - (Recall #: Z-1939-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.

Product Classification:

Class I

Date Initiated: June 17, 2019

Date Posted: July 24, 2019

Recall Number: Z-1939-2019

Event ID: 82897

Reason for Recall:

Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent recall.

Status: Ongoing

Product Quantity: 6,197

Code Information:

All serial numbers affected

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated