Food, drugs, devices › Datascope Corp.
Device recall: CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba
FDA enforcement event 95150 is a device recall by Datascope Corp. of Mahwah, NJ, initiated 8 Aug 2024 and classified Class I, with 2 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 11% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Datascope Corp. has 30 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Datascope Corp., Mahwah, NJ.
Reason for recall
"Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices."
Distribution
"International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3134-2024 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. | 5,475 units | Class I | Ongoing | 2 Oct 2024 |
| Z-3135-2024 | CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. | 5,475 units | Class I | Ongoing | 2 Oct 2024 |
Context
Other enforcement events for Datascope Corp.
All 30 events for Datascope Corp.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.