Abiomed, Inc. recalls Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for…
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of…
Read the official notice →- Date
- 2024-01-17
- Country
- United States
- Brand
- Abiomed
- Product
- Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for…
- Classification
- Class II
- Units
- Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-02-28
USAbiomed, 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 → - US
Abiomed, Inc. recalls Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella…
IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR,…Official notice → - 2024-01-10
- US
Abiomed, Inc. recalls Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella…
The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature;…
- 2023-12-13
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Pump not detected as connected to controller due to software issue.
- 2023-08-09
- US
Abiomed, Inc. recalls Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the…
FDA · DeviceAbiomed, Inc.US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA,…Official notice →
Other drugs & medical recalls in the United States
- 2024-01-17
- US
Boston Scientific Corporation recalls Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application…
The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
FDA · DeviceBoston Scientific CorporationDistribution was nationwide, including Guam, Puerto Rico, and the U.S. Virgin…Official notice → - US
Townsend Design recalls SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
FDA · DeviceTownsend DesignUS: AL AR AZ CA CO CT DC DE FL GA IA ID IL IN KENT KS KY LA MA MD ME MI MN MO…Official notice → - US
Baxter Healthcare Corporation recalls Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c)…
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or…
- US
Olympus Corporation of the Americas recalls OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light…
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
- US
Bard Peripheral Vascular Inc recalls Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM;…
The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy…
FDA · DeviceBard Peripheral Vascular IncWorldwide - US Nationwide distribution including in the states of PR, IL, MA,…Official notice → - US
Becton, Dickinson and Company, BD Biosciences recalls CD11b APC: ASR, REF: 340936, and CE, REF: 333143
In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed…
FDA · DeviceBecton, Dickinson and Company, BD BiosciencesWorldwide - US Nationwide distribution including in the states of IL, MN, FL,…Official notice →