FDA-Device2026-03-11Class IIMISBRANDING
Datascope CS300 IABP recalled for inaccurate battery specifications
What this means
Datascope Corp. has identified that the battery runtime and cycle specifications in the instruction manual for the CS300 IABP (intra-aortic balloon pump) device need to be corrected. The device itself is safe to use, but the written specifications may not accurately reflect actual battery performance.
- If you use or operate a CS300 IABP device, contact Datascope Corp. for updated instructions or clarification on correct battery specifications
- Do not rely on the current printed or digital Instructions for Use until you receive the correction
The agency's original wording
Hazard
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
10,897 units
Manufactured in
1300 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
CS300 IABP. Software Version CS300 IABP C.01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1487-2026Want us to check the next one for you?
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