Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34,…
The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
Read the official notice →- Date
- 2023-01-25
- Country
- United States
- Brand
- Datascope
- Product
- Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34,…
- Classification
- Class I
- Units
- Worldwide Distribution - US Nationwide and the countries of Albania, Angola,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Datascope recalls
- 2023-03-15
USDatascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of…
- US
Datascope Corp. recalls Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45…
An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the…
FDA · DeviceDatascope Corp.Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ,…Official notice → - US
Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers…
An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the…
FDA · DeviceDatascope Corp.Worldwide Distribution: US (nationwide) and OUS (Foreign) ARGENTINA,…Official notice → - 2022-11-02
- US
Datascope Corporation recalls LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy.…
FDA · DeviceDatascope CorporationNo US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile,…Official notice → - 2022-09-14
- US
Datascope Corporation recalls MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Certain lots containing undersized dilator.
FDA · DeviceDatascope CorporationAwaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech…Official notice → - 2021-12-22
- US
Datascope Corp. recalls Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83,…
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic…
Other drugs & medical recalls in the United States
- 2023-01-25
- US
Mobius Imaging, LLC recalls MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for users to consider…
FDA · DeviceMobius Imaging, LLCWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
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FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide and the countries of Armenia,…Official notice → - US
Cardiac Assist, Inc recalls SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC…
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Amerisource Health Services LLC recalls Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus,…
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