Recall Z-0916-2026— Datascope Corp.
Class II · Ongoing
Class II FDA medical device recall by Datascope Corp., initiated 2025-11-04. It names 3 FDA 510(k) clearances: K181122, K151254, K112372. Product: Cardiosave Hybrid. Intra-Aortic Balloon Pump system.. Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023..
- Recalling firm
- Datascope Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-11-04
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
3 on FDA's record- K181122 — CARDIOSAVE Intra-Aortic Balloon Pump
- K151254 — CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
- K112372 — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Reason for recall
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Data sourced from openFDA. This site is unofficial and independent of the FDA.