CS300 Intra-Aortic Balloon Pump — Class I medical device recall Z-1944-2019
Ongoing recall by Datascope Corp., reported 2019-07-24, distributed nationwide. If battery maintenance is not performed per instructions, the battery may provide less than the minimum run ti
| Recall number | Z-1944-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2019-06-17 |
| Classified | 2019-07-15 |
| Reported by FDA | 2019-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 16,656 |
Product
CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.
Reason for recall
If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1944-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.