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U.S. Department of Health and Human Services

Class 1 Device Recall Cardiosave Hybrid IntraAortic Balloon Pump

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 Class 1 Device Recall Cardiosave Hybrid IntraAortic Balloon Pumpsee related information
Date Initiated by FirmJune 17, 2019
Date PostedJuly 16, 2019
Recall Status1 Open3, Classified
Recall NumberZ-1939-2019
Recall Event ID 82897
510(K)NumberK112372 K151254 K163542 K181122 
Product Classification System, balloon, intra-aortic and control - Product Code DSP
ProductCardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
Code Information All serial numbers affected
Recalling Firm/
Manufacturer
Datascope Corp.
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information ContactMs. Marylou Insinga
973-709-7442
Manufacturer 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.
FDA Determined
Cause 2
Use error
ActionOn 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 Commerce6,197
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DSP
510(K)s with Product Code = DSP
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