FDA Device recall Z-1941-2019
CS100 Intra-Aortic Balloon Pump, English, 110V
- FDA Device
- Class I
- ongoing
- Published 2019-07-24
On 2019-07-24 the FDA classified a Class I recall of CS100 Intra-Aortic Balloon Pump, English, 110V by Datascope, citing if battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being offered.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1941-2019 |
| 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
CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.
Reason
If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being offered.
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-1941-2019%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.