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53 reported ongoing
53 records in this archive. Latest source date Feb 6, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during t...
Class IIReported ongoing
Distribution: Distribution list not yet provided.
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 display head and base unit.
Class IReported ongoing
Distribution: Worldwide Distribution: US (nationwide) and OUS (Foreign) ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, BRUNEI , BULGARIA, CANADA, CHILE, CHINA, ...
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 display head and base unit.
Class IReported ongoing
Distribution: Worldwide Distribution: US (nationwide) and OUS (Foreign) ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, BRUNEI , BULGARIA, CANADA, CHILE, CHINA, ...
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 hemodynamic stability of the supported patient ...
Class IReported ongoing
Distribution: Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, ...
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 hemodynamic stability of the supported patient ...
Class IReported ongoing
Distribution: Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, ...
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 helium will not be replenished when docke...
Class IIReported ongoing
Distribution: US Nationwide. Global Distribution.
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 helium will not be replenished when docke...
Class IIReported ongoing
Distribution: US Nationwide. Global Distribution.
Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
Class IIReported ongoing
Distribution: Nationwide US distribution. Worldwide international distribution.
Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
Class IIReported ongoing
Distribution: Nationwide US distribution. Worldwide international distribution.
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.
Class IReported ongoing
Distribution: Worldwide Distribution - US Nationwide and the countries of Albania, Angola, Argentina, Australia, Austria, AZERBAIJAN, BAHRAIN, BANGLADESH, Barbados, Belarus, Belgium, BOSNIA a...
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.
Class IReported ongoing
Distribution: Worldwide Distribution - US Nationwide and the countries of Albania, Angola, Argentina, Australia, Austria, AZERBAIJAN, BAHRAIN, BANGLADESH, Barbados, Belarus, Belgium, BOSNIA a...
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 instability.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide.
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 instability.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 53 records, including 53 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.