FDA Device recall Z-1486-2026
CS100 IABP. Software Version CS100 IABP Q.01
- FDA Device
- Class II
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class II recall of CS100 IABP. Software Version CS100 IABP Q.01 by Datascope, citing the firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1486-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-23 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Datascope |
| Distribution | US |
Product
CS100 IABP. Software Version CS100 IABP Q.01.
Reason
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Identifiers
| code_info | All Model No; All UDI; All Serial No. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1486-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.