Abiomed, Inc. recalls Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge…
Read the official notice →- Date
- 2026-11-04
- Country
- United States
- Brand
- Abiomed
- Product
- Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
- Classification
- Class I
- Units
- Worldwide Distribution: US (nationwide) and OUS (foreign) to countries:…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-09-30
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,…
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system…
FDA · DeviceAbiomed, Inc.Worldwide - US Nationwide and the countries of Austria, Belgium, Canada,…Official notice →- 2026-09-23
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,…
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
FDA · DeviceAbiomed, Inc.Domestic: Nationwide Distribution. International: United Arab Emirates,…Official notice →- 2026-07-22
Abiomed, Inc. recalls ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart…
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr…
FDA · DeviceAbiomed, Inc.Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium…Official notice →- 2026-07-01
Abiomed, 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
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 →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 →
USOther drugs & medical recalls in the United States
- 2026-11-04
ZIEHM-ORTHOSCAN INC recalls Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the cart.
FDA · DeviceZIEHM-ORTHOSCAN INCWorldwide - US Nationwide distribution in the states of AZ , CA , CO , CT , FL…Official notice →Medtronic, Inc. recalls OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure" Model 3930M lead…
Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty.
FDA · DeviceMedtronic, Inc.US Nationwide distribution including in the states of AZ, CA, CT, DE, FL, GA,…Official notice →Ethicon, LLC recalls ETHILON Nylon Suture, Product Code 697G
Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury,…
MSN Laboratories Private Limited (Formulations Division,… recalls Atorvastatin Calcium Tablets, USP, 40mg, 1000 tablets per bottle, Rx only, Manufactured by: MSL…
Presence of Foreign Tablets/Capsules
FDA · DrugMSN Laboratories Private Limited (Formulations Division,…Nationwide in the USA.Official notice →Brandywine Pharmaceuticals, LLC recalls Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West…
CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
Meitheal Pharmaceuticals, Inc recalls Vecuronium Bromide for Injection, 10mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for Meitheal Pharmaceuticals,…
Labeling: Label Lacks Warning or Rx Legend