Recall Z-0931-2026— Datascope Corp.
Class III · Ongoing
Class III FDA medical device recall by Datascope Corp., initiated 2025-10-23. It names 4 FDA 510(k) clearances: K181122, K163542, K151254 and 1 more. Product: Cardiosave Hybrid. Reason: The IFU addendum updates the Vibration and Shock Table to reference the correct standards..
- Recalling firm
- Datascope Corp.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2025-10-23
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
4 on FDA's record- K181122 — CARDIOSAVE Intra-Aortic Balloon Pump
- K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
- 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
Reason for recall
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Data sourced from openFDA. This site is unofficial and independent of the FDA.