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;…
Read the official notice →- Date
- 2024-01-10
- Country
- United States
- Brand
- Abiomed
- Product
- Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella…
- Classification
- Class II
- Units
- Domestic distribution nationwide.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-02-21
USAbiomed, 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 → - 2024-01-17
- US
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…
FDA · DeviceAbiomed, Inc.Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX…Official notice → - 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 → - 2023-07-26
- US
Abiomed, Inc. recalls Impella LD intravascular micro axial blood pump, Product Number 005082
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has…
Other drugs & medical recalls in the United States
- 2024-01-17
- US
Dr. Reddy's Laboratories, Inc. recalls Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090,…
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
- 2024-01-10
- US
Zimmer Biomet Spine Inc. recalls Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw…
FDA · DeviceZimmer Biomet Spine Inc.US Nationwide distribution in the states of MN, NE.Official notice → - US
Philips Respironics, Inc. recalls Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B…
The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10…
FDA · DevicePhilips Respironics, Inc.Worldwide distribution: US (nationwide)-AK, AL, AR, AZ, CA, CO, CT, DE, FL,…Official notice → - US
Natus Medical Incorporated recalls EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
FDA · DeviceNatus Medical IncorporatedUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - US
Beaver Visitec International, Inc. recalls Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
One lot of Part Number 373025, Xstar¿ Kojo Safety Slit Knife 2.5mm 45¿ bevel up, incorrectly contains a bevel down blade instead of a bevel up blade.
- US
Beaver Visitec International, Inc. recalls Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807
One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade.
FDA · DeviceBeaver Visitec International, Inc.International distribution to the countries of Belgium, China, France,…Official notice →