Datascope Corp. 2024-10-02 Health critical FDA
Health · FDA · Recall #FDA-Z-3134-2024
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to… Recall
Issued October 2, 2024 · Datascope Corp.
In October 2024, Datascope Corp. recalled the CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Datascope Corp. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Datascope Corp.
- Category
- Health
- Recall date
- October 2, 2024
- Units affected
- Not reported
- Sold at
- International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CAN
- Recall number
- FDA-Z-3134-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Datascope Corp. has 7 recalls in our database, including 3 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.