Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,…
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper…
Read the official notice →- Date
- 2026-06-03
- Country
- United States
- Brand
- Abiomed
- Product
- Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,…
- Classification
- Class I
- Units
- Worldwide distribution - US Nationwide and the countries of Canada, Denmark,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Abiomed recalls
- 2026-07-01
USAbiomed, Inc. recalls Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413,…
Potential for thrombus formation during prolonged use of the introducer.
FDA · DeviceAbiomed, Inc.Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA…Official notice →- 2026-06-24
- US
Abiomed, Inc. recalls Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
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.
FDA · DeviceAbiomed, Inc.US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to…Official notice → - US
Abiomed, Inc. recalls Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes:…
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2026-06-03
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC); Product Code: 0042-0000-US;
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;…
FDA · DeviceAbiomed, Inc.Worldwide - US Nationwide distribution in the states of CA, CT, FL, LA, MA,…Official notice → - 2026-04-08
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA;…
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.
FDA · DeviceAbiomed, Inc.International distribution in the country of Australia, Canada, France,…Official notice → - US
Abiomed, Inc. recalls Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and…
Increased risk of purge leaks with Generation 1 purge cassettes.
Other drugs & medical recalls in the United States
- 2026-06-03
- US
GE Medical Systems Information Technologies Inc recalls GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA;…
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF…
- US
Medtronic Neuromodulation recalls Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and The countries of Austria, France,…Official notice → - US
Devicor Medical Products Inc recalls HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
FDA · DeviceDevicor Medical Products IncWorldwide distribution - US Nationwide and the countries of Canada, Singapore.Official notice → - US
Medline Industries, LP recalls Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit SKU DYNJRA1181C; 2)…
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and…
FDA · DeviceMedline Industries, LPWorldwide - US Nationwide distribution in the US Territory of Virgin Islands…Official notice → - US
O&M HALYARD INC recalls Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
FDA · DeviceO&M HALYARD INCUS Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.Official notice → - US
Abiomed, Inc. recalls Automated Impella Controller (AIC); Product Code: 0042-0000-US;
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;…
FDA · DeviceAbiomed, Inc.Worldwide - US Nationwide distribution in the states of CA, CT, FL, LA, MA,…Official notice →