Datascope Corp.: 14 recalls on record

Recalls filed with 1 agency: FDA (14).

First recall on record: November 13, 2019. Most recent: December 17, 2025.

Risk classification: Class I: 5 · Class II: 9

Most recent recalls

DateAgencyProduct
December 17, 2025FDACardiosave Rescue. Intra-Aortic Balloon Pump system.Z-0917-2026
November 13, 2024FDAMEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01Z-0311-2025
October 2, 2024FDACARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to infl…Z-3135-2024
October 2, 2024FDACARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to infl…Z-3136-2024
October 2, 2024FDACARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to infl…Z-3134-2024
October 2, 2024FDACARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to infl…Z-3137-2024
August 2, 2023FDALINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter …Z-2223-2023
August 2, 2023FDASENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide count…Z-2217-2023
July 26, 2023FDACardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998…Z-2149-2023
May 3, 2023FDAMAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32Z-1462-2023
March 15, 2023FDACardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800…Z-1231-2023
March 15, 2023FDACardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-0…Z-1230-2023
October 6, 2021FDACardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0…Z-2615-2021
November 13, 2019FDALow Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 I…Z-0266-2020

Questions about this company

How many recalls does Datascope Corp. have?
Recalert has 14 U.S. recalls on record for Datascope Corp., published between November 13, 2019 and December 17, 2025.
What was the most recent Datascope Corp. recall?
FDA recall Z-0917-2026, published December 17, 2025: Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Which agencies have handled Datascope Corp. recalls?
Datascope Corp. appears as the recalling firm in recalls from: FDA (14).

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