Recall Z-1487-2026
Datascope Corp. · initiated January 23, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CS300 IABP. Software Version CS300 IABP C.01.
Codes / lots: All Model No; All UDI; All Serial No.
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1487-2026
- Initiated
- January 23, 2026
- Posted by FDA
- March 3, 2026
- Product code
- DSP – System, Balloon, Intra-Aortic And Control
- Quantity
- 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…
- Recalling firm
- Datascope Corp., Mahwah, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1486-2026 Class II | CS100 IABP. Software Version CS100 IABP Q.01.The firm has identified that the battery runtime and cycle specifications contained in the devices… | 01/23/2026Open, Classified |