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76 reported ongoing
79 records in this archive. Latest source date Aug 12, 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.
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Class IReported ongoing
Distribution: US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, German...
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received ser...
Class IReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, LA, MA, MI, MO, MS, ND, NY, OH, PA, TX, WY and the countries of Brazil, Canada, Colombia, Hong Kong, Italy, K...
Increased risk of purge leaks with Generation 1 purge cassettes.
Class IReported ongoing
Distribution: Worldwide distribution.
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
Class IReported ongoing
Distribution: International distribution in the country of Australia, Canada, France, Germany, Kuwait.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Device packaged in incorrect outer box carton.
Class IIReported ongoing
Distribution: International distribution to the country of Australia and Taiwan.
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Class IReported ongoing
Distribution: Nationwide distribution. International distribution to United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Colombia, Czechia, Germ...
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
Class IReported ongoing
Distribution: Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil, Canada, Columbia, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Isre...
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
Class IReported ongoing
Distribution: US distribution to AR, AZ, CA, CO, CT, FL, GA, ID, MA, MI, MO, MS, NJ, NY, OH, PA, TX. International distribution to Canada, Germany, Great Britian, Italy, Netherlands, Norway.
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Class IReported ongoing
Distribution: Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei Darussalam, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, ...
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary...
Class IReported ongoing
Distribution: Domestic: Nationwide Distribution International: Canada
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary...
Class IReported ongoing
Distribution: Domestic: Nationwide Distribution International: Canada
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update th...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Ge...
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update th...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Ge...
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update th...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Ge...
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update th...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Ge...
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update th...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Ge...
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 79 records, including 76 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.