Atrium Medical Corporation recalls Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac…
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Read the official notice →- Date
- 2023-11-22
- Country
- United States
- Brand
- Atrium Medical
- Product
- Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal…
- Classification
- Class II
- Units
- Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Atrium Medical recalls
- 2023-12-13
USAtrium Medical Corporation recalls Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
- US
Atrium Medical Corporation recalls Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
FDA · DeviceAtrium Medical CorporationUS: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TXOfficial notice → - 2023-11-22
- US
Atrium Medical Corporation recalls Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection…
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - 2023-04-05
- US
Atrium Medical Corporation recalls Express Mini 500 Dry Seal Chest Drain, Part Number 16400
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the…
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide and the countries of United Arab…Official notice → - 2022-11-23
- US
Atrium Medical Corporation recalls Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
FDA · DeviceAtrium Medical CorporationUS Nationwide distribution in the state of VA.Official notice → - 2022-07-06
- US
Atrium Medical Corporation recalls Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or…
Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and…
Other drugs & medical recalls in the United States
- 2023-11-22
- US
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
FDA · DevicePhysio-Control, Inc.US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.Official notice → - US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient…
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
FDA · DeviceIon Beam Applications S.A.Worldwide - US Nationwide distribution in the states of Arkansas, Florida,…Official notice → - US
Philips North America Llc recalls Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and…
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect…
FDA · DevicePhilips North America LlcNationwide Foreign: Austria Belgium Canada China Estonia France Germany…Official notice → - US
Siemens Medical Solutions USA, Inc recalls Mobilett Mira wireless (VA20) mobile x-ray system(s)
Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual…
- US
- US
Omega & Delta Co., Inc. recalls Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.