FDA Device recall Z-1928-2018
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-…
- FDA Device
- Class I
- ongoing
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class I recall of 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-… by Maquet Datascope Cardiac Assist Division, citing ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1928-2018 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2018-05-03 |
| Published | 2018-06-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Maquet Datascope Cardiac Assist Division |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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 |
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
Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
Identifiers
| code_info | All Serial Numbers distributed from 03/06/2012 to 04/26/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1928-2018%22
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