Lower riskMedical device recall · FDA · Published June 17, 2019
Datascope CS100 Intra-Aortic Balloon Pump Recall: Battery Run Time Risk
Datascope recalls CS100 Intra-Aortic Balloon Pumps with serial numbers 0998-00-3013-55 due to potential battery run time issues. Revised labeling and training are provided to address the risk.
If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
“Datascope CS100 Intra-Aortic Balloon Pump Recall: Battery Run Time Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67657-datascope-cs100-intra-aortic-balloon-pump-recall-battery-run-time. Based on FDA recall #Z-1942-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1942-2019%22&limit=1).
The FDA announced on June 17, 2019, that Datascope Corp. is recalling the CS100 Intra-Aortic Balloon Pump due to a battery maintenance hazard. The agency issued recall number Z-1942-2019 for the device used in cardiovascular applications.
According to the FDA, if battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. The recall classification is Class I.
Context
GovInfoNow's records show Datascope Corp. has 29 other recalls on record since October 3, 2019. Recent similar recalls include the Thoratec HeartMate 3 LVAS Kits Recall (May 13, 2026), the Fresenius Kabi Ivenix Infusion System Software Recall (May 6, 2026), and the Philips Cardiac Workstation 7000 recall (July 1, 2026).
How to tell if you have this one
Check the serial number on the device, which is 0998-00-3013-55 for the recalled model. The device is designed for cardiovascular use and operates on 220V power.
Brand
Datascope
Category
Medical device
FDA recall event · 6 products
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
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 number
Product, codes & lots
Quantity
Z-1939-2019
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.; All serial numbers affected
6,197
Z-1940-2019
Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.; All serial numbers affected
6,197
Z-1941-2019
CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.; All serial numbers affected
16,656
Z-1942-2019
CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.; All serial numbers affected
16,656
Z-1943-2019
CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.; All serial numbers affected
16,656
Z-1944-2019
CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.; All serial numbers affected
16,656
Based on the official FDA remedy
What to do — step by step
Check Battery Maintenance
Ensure battery maintenance is performed correctly to maintain the minimum required run time.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution. US Nationwide, AFGHANISTAN , HUNGARY , PANAMA , ALGERIA , ICELAND , PARAGUAY , ARGENTINA , INDIA , PERU , AUSTRALIA , INDONESIA , PHILIPPINES , AUSTRIA , IRAN , POLAND , AZERBAIJAN , IRAQ , PORTUGAL , BAHRAIN ,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1942-2019 (June 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1942-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.