CS300 IABP. Software Version CS300 IABP C.01.
FDA device recall Z-1487-2026 · posted 2026-03-03 · Open, Classified
Recall details
- Recalling firm
- Datascope Corp.
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DSP
- Quantity affected
- 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 A
- Date initiated
- 2026-01-23
- Date posted
- 2026-03-03
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (K172305) | Datascope Corp. | 2017-10-12 |
| DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM (K063525) | Datascope Corp. | 2007-01-05 |