Edwards Lifesciences, LLC recalls Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Read the official notice →- Date
- 2023-12-06
- Country
- United States
- Brand
- Edwards Lifesciences
- Product
- Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.
- Classification
- Class II
- Units
- US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Edwards Lifesciences recalls
- 2026-05-20
USEdwards Lifesciences, LLC recalls Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
FDA · DeviceEdwards Lifesciences, LLCWorldwide - US Nationwide distribution including in the states of AR, AZ, CA,…Official notice →- 2025-07-16
- US
Edwards Lifesciences, LLC recalls Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A…
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
FDA · DeviceEdwards Lifesciences, LLCWorldwide - US Nationwide distribution including in the states of ALABAMA,…Official notice → - 2023-11-15
- US
Edwards Lifesciences, LLC recalls Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
- 2023-09-06
- US
Edwards Lifesciences, LLC recalls PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery…
FDA · DeviceEdwards Lifesciences, LLCInternational distribution to the countries of Austria, Belgium, Switzerland,…Official notice → - 2023-04-19
- US
Edwards Lifesciences, LLC recalls Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable…
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
FDA · DeviceEdwards Lifesciences, LLCUS: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO…Official notice → - 2022-11-09
- US
Edwards Lifesciences, LLC recalls Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty…
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
FDA · DeviceEdwards Lifesciences, LLCWorldwide distribution - U.S. Nationwide distribution including in the states…Official notice →
Other drugs & medical recalls in the United States
- 2023-12-06
- US
Siemens Healthcare Diagnostics Inc recalls RAPIDPOINT 500 Blood Gas System
There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The…
FDA · DeviceSiemens Healthcare Diagnostics IncDomestic: Nationwide Distribution. Foreign: Albania, Algeria, Angola,…Official notice → - US
Medtronic Inc. recalls ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to…
FDA · DeviceMedtronic Inc.US and Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic,…Official notice → - US
Aizu Olympus Co., Ltd. recalls PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or…
FDA · DeviceAizu Olympus Co., Ltd.Domestic distribution to FL, KY, MA, NJ, NY, and PAOfficial notice → - US
EMD Millipore Corporation recalls Lugol s Iodine Solution 500ML, Part Number 624-71
Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. With an improper seal the Assay (current specification of 24.8 to 27.2 mL) is expected to continue to drop…
- US
Abbott Molecular, Inc. recalls Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse…
Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
- US
Intuitive Surgical, Inc. recalls Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
FDA · DeviceIntuitive Surgical, Inc.US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South…Official notice →