Summary
The FDA issued a Class II for CS100 IABP. Software Version CS100 IABP Q.01. by Datascope Corp.. Reason: The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated..
Details
Source
Device Recall
External ID
Z-1486-2026
Action Date
2026-03-11
Status
Ongoing
Category
device
Product Description
CS100 IABP. Software Version CS100 IABP Q.01.
Lot/Code Info: All Model No; All UDI; All Serial No.
Quantity Affected: 10,897 units
Reason for Recall
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-23
Company
Mahwah, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 133 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Datascope Corp. has 58 FDA actions in our database, including 58 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Datascope Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Datascope Corp. have FDA actions?
Datascope Corp. has 58 FDA actions in our database, including 58 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1486-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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