Recall Z-1487-2026 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
CS300 IABP. Software Version CS300 IABP C.01.
| Date | Mar 3, 2026 (initiated Jan 23, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 | 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, Czec |
| FDA record | Open on fda.gov |