Cardiosave Hybrid Intra-Aortic Balloon Pump recall: Labeling Error
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
Why was Cardiosave Hybrid Intra-Aortic Balloon Pump recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers affected
- Product
- Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
- Recalling firm
- Datascope Corp.
- Quantity
- 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.
- Recall date
- July 24, 2019
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)