Z-1486-2026Class II

CS100 IABP. Software Version CS100 IABP Q.01

Name: Z-1486-2026 CS100 IABP. Software Version CS100 IABP Q.01
Creator: Datascope Corp.
Published: 2026-01-23
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2026-01-23 / Open, Classified / root cause: labeling and UDI

FDA source

Datascope Corp. began a recall of CS100 IABP. Software Version CS100 IABP Q.01 on 2026-01-23. FDA classified it as Class II and gives the reason as "The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1486-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-23
Posted: 2026-03-03
Recalling firm: Datascope Corp.
Product: CS100 IABP. Software Version CS100 IABP Q.01.
Product code: DSP System, Balloon, Intra-Aortic And Control
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: An URGENT MEDICAL DEVICE CORRECTION notice dated January 2026 was mailed to consignees. The notification informs consignees of an updated battery specification to be updated in the IFU. Consignees are to forward the notice to all users in their facility, confirm users are aware of the IFU clarifications, and complete and return the provided Response Form. If product was further distributed, the provided notification is to be forwarded to them. Consignees with any questions should contact Datascope/Getinge Cusotmer Support at 1-888-943-8872, options 4, 2, 1.
Quantity in commerce: 10,897 units
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.
Product codes and lots: All Model No; All UDI; All Serial No.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1486-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1486-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-03-03
Z-1487-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-03-03

Product code DSP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)