FDA Device recall Z-1278-2023
Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
- FDA Device
- Class II
- ongoing
- Published 2023-03-29
On 2023-03-29 the FDA classified a Class II recall of Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140 by Datascope, citing there is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1278-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-28 |
| Published | 2023-03-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Datascope |
| Distribution | n/a |
Product
Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
Reason
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
Identifiers
| code_info | Serial Numbers: DR349559C2 DR352554E2 DR354264F2 DR350872D2 DR351891D2 DR349620C2 DR354572F2 DR353203E2 DR354251F2 DR35…Serial Numbers: DR349559C2 DR352554E2 DR354264F2 DR350872D2 DR351891D2 DR349620C2 DR354572F2 DR353203E2 DR354251F2 DR352588E2 DR352572E2 DR350988D2 DR347950B2 DR348991C2 DR351959D2 DR348566B2 DR353163E2 DR351013D2 DR349563C2 DR352526E2 DR351919D2 DR352548E2 DR351927D2 DR344801L1 DR352926E2 DR353698F2 DR352211D2 DR350876D2 DR354556F2 DR350998D2 DR353686F2 DR347941B2 DR354568F2 DR354254F2 DR348987C2 DR353693F2 DR351004D2 DR351330D2 DR348525B2 DR352593E2 DR348530B2 DR351923D2 DR352571E2 DR351907D2 DR351331D2 DR350854D2 DR352589E2 DR347949B2 DR354551F2 DR351872D2 DR350997D2 DR348999C2 DR352537E2 DR351017D2 DR352585E2 DR351403D2 DR350878D2 DR349527C2 DR349558C2 DR352573E2 DR347945B2 DR354244F2 DR352167D2 DR351323D2 DR352199D2 DR352557E2 DR354583F2 DR350863D2 DR348552B2 DR348561B2 DR351376D2 DR353162E2 DR351894D2 DR352192D2 DR354232F2 DR347936B2 DR350994D2 DR345595L1 DR348982C2 DR350867D2 DR351374D2 DR350849D2 DR345642L1 DR354557F2 DR351036D2 DR352591E2 DR353681F2 DR351031D2 DR349568C2 DR352 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1278-2023%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.