FDA Device recall Z-0099-2019
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
- FDA Device
- Class I
- ongoing
- Published 2018-11-07
On 2018-11-07 the FDA classified a Class I recall of Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 by Maquet Datascope Cardiac Assist Division, citing there is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0099-2019 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2018-09-20 |
| Published | 2018-11-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Maquet Datascope Cardiac Assist Division |
| Distribution | US |
Product
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Reason
There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
Identifiers
| code_info | UDI - 10607567108391 All Serial Numbers |
|---|
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-0099-2019%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.