CARDIOSAVE Hybrid Intra-Aortic Balloon Pump — Class I medical device recall Z-1928-2018
Ongoing recall by Maquet Datascope Corp - Cardiac Assist Division, reported 2018-06-06, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation
| Recall number | Z-1928-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Datascope Corp - Cardiac Assist Division, Mahwah, NJ, United States |
| Recall initiated | 2018-05-03 |
| Classified | 2018-05-31 |
| Reported by FDA | 2018-06-06 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CL, CN, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GH, GT, HK, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KW, LB, LK, LT, MA, MX, MY, NG, NL, NO, OM, PH, PK, PL, PT, RS, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, VN, ZA |
| Quantity | 4,300 |
| Model numbers | 0998-00-0800-XX, 0998-UC-0800-XX |
Product
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
Reason for recall
Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
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-1928-2018. 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.