FDA Device recall Z-1944-2019
CS300 Intra-Aortic Balloon Pump, English, 220V
- FDA Device
- Class I
- ongoing
- Published 2019-07-24
On 2019-07-24 the FDA classified a Class I recall of CS300 Intra-Aortic Balloon Pump, English, 220V by Datascope, citing if battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1944-2019 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2019-06-17 |
| Published | 2019-07-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Datascope |
| Distribution | US |
Product
CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.
Reason
If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
Identifiers
| code_info | All serial numbers affected |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1944-2019%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.