FDA-Device2026-03-11Class IIMISBRANDING
Datascope CS100 IABP recalled for inaccurate battery specifications in instructions
What this means
Datascope Corp. identified that the battery runtime and cycle specifications in the instruction manual for the CS100 IABP (intra-aortic balloon pump) device are incorrect and need to be updated. The device itself is not defective, but users may rely on outdated battery information.
- Contact Datascope Corp. for updated battery runtime and cycle specifications for your device
- Do not discard your device; the hazard involves the manual, not the equipment itself
- If you use this device clinically, consult with your facility's biomedical or clinical team for guidance
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
CS100 IABP. Software Version CS100 IABP Q.01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1486-2026Want us to check the next one for you?
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