Lower riskMedical device recall · FDA · Published January 23, 2026
Datascope CS300 IABP Software Update Needed for Safety
Datascope recalls CS300 IABP devices with software version C.01 due to outdated battery specifications in instructions. Affected units may have safety risks requiring software update.
“Datascope CS300 IABP Software Update Needed for Safety.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50108-datascope-cs300-iabp-software-update-needed-for-safety. Based on FDA recall #Z-1487-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1487-2026%22&limit=1).
The FDA announced on Jan. 23, 2026, that Datascope Corp. is recalling its CS300 IABP devices because the battery runtime and cycle specifications in the Instructions for Use need to be updated. The recall affects 10,897 units distributed worldwide.
How to tell if you have it
Datascope CS300 IABP
Software Version CS300 IABP C.01
The hazard
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Context
GovInfoNow's records show Datascope Corp. has 29 other recalls on record since June 17, 2019. Other recent recalls of similar products include a Feb. 6, 2026 recall of the Battery Charging Station Model 0998-00-0802 for a protruding screw and a Nov. 4, 2025 Cardiosave Rescue Intra-Aortic Balloon Pump recall for preventative maintenance updates.
How to tell if you have this one
Check for CS300 IABP devices with software version C.01. All model numbers, UDI, and serial numbers are affected.
Brand
Datascope
Category
Medical device
FDA recall event · 2 products
All 2 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 II
Status
Ongoing
Distribution
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.
Recall number
Product, codes & lots
Z-1486-2026
CS100 IABP. Software Version CS100 IABP Q.01.; All Model No; All UDI; All Serial No.
Z-1487-2026
CS300 IABP. Software Version CS300 IABP C.01.; All Model No; All UDI; All Serial No.
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your device's software version by checking the device settings or documentation.
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 and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria,…” 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 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
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-1487-2026 (January 23, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1487-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.