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…
Read the official notice →- Date
- 2026-07-22
- Country
- United States
- Brand
- Abiomed
- Product
- ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart…
- Classification
- Class I
- Units
- Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
USAbiomed, 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
- US
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 → - 2026-07-01
- US
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
- 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) 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…
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Denmark,…Official notice →
Other drugs & medical recalls in the United States
- 2026-07-22
- US
Intuitive Surgical, Inc. recalls da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution in the states of NJ, OR, NY, FL, AL,…Official notice → - US
Olympus Corporation of the Americas recalls Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Canada, Japan, EU,…Official notice → - US
Argon Medical Devices, Inc recalls General Biospy Tray, REF: GUTS1000
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA · DeviceArgon Medical Devices, IncDistribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.Official notice → - US
Oscor Inc. recalls Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart…
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
- US
CareFusion 213, LLC recalls BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL)…
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
- US