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…
Read the official notice →- Date
- 2024-09-11
- Country
- United States
- Brand
- Abiomed
- Product
- ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-10-01
USAbiomed, 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 →- 2025-08-06
- US
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
FDA · DeviceAbiomed, Inc.Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei…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…
- 2024-07-24
- 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.
- 2024-02-28
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems…
Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.
- 2024-02-21
- US
Abiomed, Inc. recalls Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella…
New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR,…Official notice →
Other drugs & medical recalls in the United States
- 2024-09-18
- US
Elevate Oral Care recalls Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the…
LABELING: LABEL MIX-UP.
FDA · DrugElevate Oral Care120 direct customers, Nationwide US. No foreign, DOD/VA.Official notice → - US
PREQUEL SKIN recalls BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8…
Microbial contamination of non-sterile Products -
- 2024-09-11
- US
Beckman Coulter Biomedical GmbH recalls PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the…
FDA · DeviceBeckman Coulter Biomedical GmbHWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers…
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution.Official notice → - US
Mindray DS USA, Inc. dba Mindray North America recalls Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an…
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System…
FDA · DeviceMindray DS USA, Inc. dba Mindray North AmericaUS Distribution to states of: California, Georgia, Kentucky, Mississippi, New…Official notice → - US
CareFusion 303, Inc. recalls BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.Official notice →