Manufacturer
95 recalls in our database name Edwards Lifesciences, LLC as the manufacturing or recalling firm.
Of the 95 recalls from Edwards Lifesciences, LLC we have scored against our rubric, 4 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 15 (16%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Edwards Lifesciences is updating labeling for the Edwards EVOQUE tricuspid delivery system (REF 9850TDS) to provide a warning if valve replacement delivery system functionality becomes compromised.
Edwards FEM-FLEX II Femoral Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 847 units affected.
Edwards Optisite OPTI18 Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 13,240 units affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII018A, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 13,240 units affected.
Edwards Optisite OPTI16 Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 27,022 units affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII018AS, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 558 units affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII016A, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 6,801 units affected.
Edwards Lifesciences is recalling 1417 FloTrac Sensors used for intravascular pressure monitoring due to potential flushing difficulties during kit setup. No illnesses or injuries have been reported.
Edwards Lifesciences is recalling 33,327 Acumen IQ Sensors used for intravascular pressure monitoring due to potential flushing difficulties during setup. The devices are distributed across the US and internationally.
Edwards Lifesciences is recalling 168,014 TruWave with Vamp pressure monitoring kits due to potential flushing difficulties during setup. The recall affects devices distributed across the US and internationally.
Edwards Lifesciences is recalling 118,570 units of the TruWave Pressure Monitoring Set due to potential flushing difficulties during setup. The device is used for hemodynamic pressure monitoring.
Edwards Lifesciences' FloTrac Sensor with Vamp System is being recalled due to potential flushing difficulties during setup of the pressure monitoring kit. No injuries have been reported.
Edwards Lifesciences is recalling Acumen IQ intravascular pressure monitoring sensors (6,714 units) due to potential flushing difficulties during setup of the pressure monitoring kit.
Edwards Lifesciences is recalling Fogarty Thru-Lumen Embolectomy Catheters that may deflate more slowly than normal, potentially affecting device function during vascular procedures.
Edwards Lifesciences is recalling 92 units of the PASCAL Precision Transcatheter Valve Repair System due to a manufacturing defect in the release mechanism that could cause increased resistance and potential improper implant positioning.
Edwards Lifesciences is recalling Swan-Ganz CCOmbo V thermodilution catheters because the distal end may bend beyond its intended curvature, potentially causing the patient monitoring device to display an error message.
Edward Lifesciences Swan-Ganz thermodilution catheters may bend during use, potentially causing patient monitoring devices to display error messages. The FDA has recalled 326 affected units distributed nationwide.
Edwards Lifesciences is recalling 715,620 Fogarty Arterial Embolectomy Catheters due to confirmed latex deterioration in the pouch packaging. The material degradation could affect device performance during use.
Edwards Lifesciences is recalling Fogarty Biliary Balloon Probes due to confirmed latex deterioration in pouches. The recall affects 26,560 units distributed worldwide.
Edwards Lifesciences FORE-SIGHT ELITE Absolute Tissue Oximeter (Model 01-06-3000) is recalled because StO2 (tissue oxygen saturation) values may read inaccurately low when used with the large sensor on arms or legs, potentially leading to inappropriate treatment.
Edwards Lifesciences is recalling 8,389 FORE-SIGHT ELITE Tissue Oximeter modules that may display inaccurately low oxygen saturation values when used in certain body locations, potentially leading to inappropriate treatment decisions.
Edwards Lifesciences is recalling its PediaSat Oximetry Catheter Set due to potential for internal leaks within the device.
Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks within the catheters. The recall affects 178 units distributed across multiple US states and international locations.
Edwards Lifesciences is recalling PediaSat Oximetry Catheter Kits due to potential internal leaks within the devices. The recall involves 218 units distributed across multiple U.S. states and internationally.
Edwards Lifesciences is recalling the Edwards PediaSat Oximetry Catheter Kit (REF: XT3515KTP) due to potential for internal leaks. The recall affects 70 units distributed across the US and internationally.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
Edwards Lifesciences
American medical technology company
Source: Wikidata (Q16966841), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.