Abiomed, Inc. recalls Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU;…
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Read the official notice →- Date
- 2025-08-06
- Country
- United States
- Brand
- Abiomed
- Product
- Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU;…
- Classification
- Class I
- Units
- Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-10-29
USAbiomed, Inc. recalls Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product…
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
FDA · DeviceAbiomed, Inc.Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil,…Official notice →- 2025-10-15
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1.…
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
FDA · DeviceAbiomed, Inc.Nationwide distribution. International distribution to United Arab Emirates,…Official notice → - 2025-10-01
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged,…
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…
FDA · DeviceAbiomed, Inc.US distribution to AR, AZ, CA, CO, CT, FL, GA, ID, MA, MI, MO, MS, NJ, NY, OH,…Official notice → - 2025-01-22
- US
Abiomed, Inc. recalls Impella RP Flex with SmartAssist; Product Number: 1000323;
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…
- 2024-09-11
- US
Abiomed, Inc. recalls ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
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…
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2024-07-24
- US
Abiomed, Inc. recalls Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
Other drugs & medical recalls in the United States
- 2025-08-06
- US
HeartSine Technologies Ltd recalls HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
FDA · DeviceHeartSine Technologies LtdWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - US
Implant Direct Sybron Manufacturing LLC recalls The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop…
The Drill stop kit contains incorrect components.
FDA · DeviceImplant Direct Sybron Manufacturing LLCWorldwide - US Nationwide distribution in the states of AL, FL, LA, MD, NJ,…Official notice → - US
Hamilton Medical AG recalls Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and…
Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete…
FDA · DeviceHamilton Medical AGUS Nationwide distribution in the states of NH, NY, CT, PA, IL, ME, CO, NC,…Official notice → - US
Draeger, Inc. recalls SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
FDA · DeviceDraeger, Inc.Worldwide - US Nationwide distribution including in the states of AK, AZ, CA,…Official notice → - US
Apic Yamada America recalls Molding Equipment. WCM series. Model WCM-330GL-i
Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label.
- US
Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC#…
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds