FDA recall, , Moderate risk
Datascope CS100 and CS300 Intra-Aortic Balloon Pumps
The CS100 Iabp and CS300 Iabp have battery runtime and cycle specifications that need to be updated.
Summary by Recall Canary from the FDA notice
What happened
Datascope Corp., of Mahwah, New Jersey, began a recall on January 23, 2026, for the CS100 Iabp and CS300 Iabp devices, with software versions CS100 Iabp Q.01 and CS300 Iabp C.01, because the battery runtime and cycle specifications in the Instructions for Use (IFU) need to be updated.
The FDA added the recall to its Enforcement Report and classified it on March 3, 2026, with distribution worldwide, including the US nationwide and many other countries. The recall was listed in the FDA's weekly enforcement report on March 11, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Compare these details with yours, then check the recall notice to see which units are recalled.
CS300 Iabp. Software Version CS300 Iabp C.01.
CS100 Iabp. Software Version CS100 Iabp Q.01.
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador , Estonia, France, Georgia, Germany, Ghana, Greece, Guatemala, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Maldives, Malta, Mauritius, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yemen.
- Company
- Datascope Corp.Mahwah, New Jersey
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98189
- Recall numbers
- Z-1486-2026 to Z-1487-2026
All recalls from Datascope Corp.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
