| Class 1 Device Recall Cardiosave Hybrid IntraAortic Balloon Pump | |
Date Initiated by Firm | June 17, 2019 |
Date Posted | July 16, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1939-2019 |
Recall Event ID |
82897 |
510(K)Number | K112372 K151254 K163542 K181122 |
Product Classification |
System, balloon, intra-aortic and control - Product Code DSP
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Product | Cardiosave 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 Contact | Ms. 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 |
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. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DSP 510(K)s with Product Code = DSP
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